MAUDE Adverse Event Report: PFIZER, INC. (DEVICE) ADD-VANTAGE ADDAPTOR; DEVICE DELIVERY AID; CLASS II

Lot Number 4772109

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tachycardia (2095)

Event Date 10/12/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] when she went to mix the product the ring was dislodged but the plug did not come out in order to mix the contents [product dose omission issue], when she went to mix the product the ring was dislodged but the plug did not come out in order to mix the contents [device malfunction], elevated heart rate because of this product not being infused [heart rate increased], narrative: this is a spontaneous report from a contactable pharmacist.A (b)(6) female patient had to receive diltiazem (batch/lot number: 15101dd; exp date 01mar2022) for elevated heart rate and blood pressure.Add-vantage system (lot 4772109, exp date 01apr2022) was used.Bag: sodium chloride injection (vehicle); vial diltiazem hydrochloride injection.Caller reports that she has the add-vantage bag and vial and when she went to mix the product the ring was dislodged but the plug did not come out in order to mix the contents.Attached the vial to the bag the ring dislodged but the plug remained so the product could not be diluted or mixed.Clinically the patient had an elevated heart rate and blood pressure and the nurse noticed that the medication was intended to infuse but the patient did not receive the product because it did not mix.This event happened on (b)(6) 2021.The patient was on a continuous drip and received a total of 800 mg of diltiazem over the course of 4 days.The patient got 0 mg of the product involved because it did not infuse into the patient.The patient had been hospitalized days prior to this event and was not hospitalized because of this event.The patient was receiving this product while admitted to the hospital.The patient had elevated heart rate because of this product not being infused.Action taken was unknown.Outcome of the event elevated heart rate was unknown.

Manufacturer Narrative

The complaint for "plug remained so the product could not be diluted or mixed" for lot 15101dd and parent lot 15100dd was investigated.The investigation included reviewing incoming quality and an analysis of the complaint history for the reported product type.This product is filled, labeled, and packaged by pfizer mcpherson.The final scope was determined to be 15101dd and parent lot 15100dd.No quality issues were identified during the investigation.There is no impact to the product.An ntm was not issued for the current complaint.An mdr has been filed.Per the related mdcp record (b)(4): this is medical device related.The complaint condition was not confirmed; therefore, the root cause could not be determined as manufacture or vendor related.No corrective or preventative actions were identified, the complaint was not attributed to the manufacturing processes.There are controls currently in place are sufficient for preventing and removing defective units prior to product release.Return sample evaluation: on 29nov2021 the sample was received, documented, and photographed by complaint specialist (b)(4).The sample consisted of one flexible sodium chloride container, lot 4772109, attached to one vial of diltiazem lot 15101dd.The inner cap and o-ring had been removed from the drug vial-vial port assembly but the rubber stopper was still seated in the drug vial.Using add-vantage instructions, the complaint specialist manipulated the inner cap and the o-ring back into the drug vial- vial port assembly.The inner cap and o-ring were then pulled from the drug vial-vial port assembly, successfully removing the rubber stopper and activating the drug vial.No defect was confirmed in the returned customer sample.No further analysis is warranted.

Event Description

Event verbatim [preferred term].When she went to mix the product the ring was dislodged but the plug did not come out in order to mix the contents [product dose omission issue], when she went to mix the product the ring was dislodged but the plug did not come out in order to mix the contents [device malfunction], elevated heart rate because of this product not being infused [heart rate increased], , narrative: this is a spontaneous report from a contactable pharmacist.A 77-year-old female patient had to receive diltiazem (lot number: 15101dd; exp date 01mar2022) for elevated heart rate and blood pressure.Add-vantage system (lot 4772109, exp date 01apr2022) was used.Bag: sodium chloride injection (vehicle); vial diltiazem hydrochloride injection.Caller reports that she has the add-vantage bag and vial and when she went to mix the product the ring was dislodged but the plug did not come out in order to mix the contents.Attached the vial to the bag the ring dislodged but the plug remained so the product could not be diluted or mixed.Clinically the patient had an elevated heart rate and blood pressure and the nurse noticed that the medication was intended to infuse but the patient did not receive the product because it did not mix.This event happened on (b)(6) 2021.The patient was on a continuous drip and received a total of 800 mg of diltiazem over the course of 4 days.The patient got 0 mg of the product involved because it did not infuse into the patient.The patient had been hospitalized days prior to this event and was not hospitalized because of this event.The patient was receiving this product while admitted to the hospital.The patient had elevated heart rate on (b)(6) 2021 because of this product not being infused.Action taken was unknown.Outcome of the event elevated heart rate was unknown.Product quality group provided investigational results on 09dec2021 for diltiazem hcl powder for injection 100mg 1 add-vantage vial: the complaint for "plug remained so the product could not be diluted or mixed" for lot 15101dd and parent lot 15100dd was investigated.The investigation included reviewing incoming quality and an analysis of the complaint history for the reported product type.This product is filled, labeled, and packaged by pfizer mcpherson.The final scope was determined to be 15101dd and parent lot 15100dd.No quality issues were identified during the investigation.There is no impact to the product.An ntm was not issued for the current complaint.An mdr has been filed.Per the related mdcp record (b)(4): this is medical device related.The complaint condition was not confirmed; therefore, the root cause could not be determined as manufacture or vendor related.No corrective or preventative actions were identified, the complaint was not attributed to the manufacturing processes.There are controls currently in place are sufficient for preventing and removing defective units prior to product release.Return sample evaluation: on 29nov2021 the sample was received, documented, and photographed by complaint specialist (b)(4).The sample consisted of one flexible sodium chloride container, lot 4772109, attached to one vial of diltiazem lot 15101dd.The inner cap and o-ring had been removed from the drug vial-vial port assembly but the rubber stopper was still seated in the drug vial.Using add-vantage instructions, the complaint specialist manipulated the inner cap and the o-ring back into the drug vial- vial port assembly.The inner cap and o-ring were then pulled from the drug vial-vial port assembly, successfully removing the rubber stopper and activating the drug vial.No defect was confirmed in the returned customer sample.No further analysis is warranted.Follow-up (09dec2021): this is a follow-up spontaneous report from a product quality complaint group.Updated information: investigation results.No follow-up attempts are needed.No further information is expected.

Event Description

Event verbatim [preferred term] when she went to mix the product the ring was dislodged but the plug did not come out in order to mix the contents [product dose omission issue], when she went to mix the product the ring was dislodged but the plug did not come out in order to mix the contents [device malfunction], elevated heart rate because of this product not being infused [heart rate increased].Narrative: this is a spontaneous report from a contactable pharmacist.A 77-year-old female patient had to receive diltiazem, (lot number: 15101dd; exp date 01mar2022) and intravenous from (b)(6) 2021 (batch/lot number: unknown) to (b)(6) 2021 at 100 mg (titration based on heart rate) for elevated heart rate and blood pressure and atrial fibrillation.Advantage system (lot 4772109, exp date 01apr2022) was used.Bag: sodium chloride injection (vehicle); vial diltiazem hydrochloride injection.Patient hospitalized for atrial fibrillation w/pvr.Receiving iv diltiazem, titrated to goal heart rate, patient's heart rate was increasing despite increasing the diltiazem rate, nurse then discovered that the bag of diltiazem + normal saline that was hanging was only infusing normal saline.When she activated the add system only the plastic ring came off and the ping stead affixed to the vial therefore the patient was not receiving the intended medication, since it did not transfer from the vial to the bag.Caller reports that she has the advantage bag and vial and when she went to mix the product the ring was dislodged but the plug did not come out in order to mix the contents.Attached the vial to the bag the ring dislodged but the plug remained so the product could not be diluted or mixed.Clinically the patient had an elevated heart rate and blood pressure and the nurse noticed that the medication was intended to infuse but the patient did not receive the product because it did not mix.This event happened on (b)(6) 2021.The patient was on a continuous drip and received a total of 800 mg of diltiazem over the course of 4 days.The patient got 0 mg of the product involved because it did not infuse into the patient.The patient had been hospitalized days prior to this event and was not hospitalized because of this event.The patient was receiving this product while admitted to the hospital.The patient had elevated heart rate on (b)(6) 2021 because of this product not being infused.Action taken was dose not changed.Outcome of the events was unknown.Product quality group provided investigational results on 09dec2021 for diltiazem hcl powder for injection 100mg 1 add-vantage vial: the complaint for "plug remained so the product could not be diluted or mixed" for lot 15101dd and parent lot 15100dd was investigated.The investigation included reviewing incoming quality and an analysis of the complaint history for the reported product type.This product is filled, labeled, and packaged by pfizer mcpherson.The final scope was determined to be 15101dd and parent lot 15100dd.No quality issues were identified during the investigation.There is no impact to the product.An ntm was not issued for the current complaint.An mdr has been filed.Per the related mdcp record (b)(4): this is medical device related.The complaint condition was not confirmed; therefore, the root cause could not be determined as manufacture or vendor related.No corrective or preventative actions were identified, the complaint was not attributed to the manufacturing processes.There are controls currently in place are sufficient for preventing and removing defective units prior to product release.Return sample evaluation: on 29nov2021 the sample was received, documented, and photographed by complaint specialist (b)(4).The sample consisted of one flexible sodium chloride container, lot 4772109, attached to one vial of diltiazem lot 15101dd.The inner cap and o-ring had been removed from the drug vial-vial port assembly but the rubber stopper was still seated in the drug vial.Using add-vantage instructions, the complaint specialist manipulated the inner cap and the o-ring back into the drug vial- vial port assembly.The inner cap and o-ring were then pulled from the drug vial-vial port assembly, successfully removing the rubber stopper and activating the drug vial.No defect was confirmed in the returned customer sample.No further analysis is warranted.Product quality group provided investigational results on 16dec2021 for sodium chloride inj 0.9% 100 ml life care flexible container lot# 4772109: corrective / preventive action: no defects were confirmed for the reported complaint.Therefore, no corrective or preventive actions are required.Conclusion: the customer experience could not be confirmed as a sample was not received for evaluation; therefore, further investigation could not be performed.Review of the batch record, investigation history, and lot history did not identify any related incidents with an austin manufacturing related root cause.Scope of compl.Investigation : quality impact/quality hold/scope of investigation: the scope of this investigation is limited to the event reported by the customer.A defect was not confirmed as customer samples were not provided.Investigation covering review of complaint/investigation history, certificate of analysis, mq final product testing, and batch record did not identify any related incidents.Based on the investigation findings there is no impact to the quality of the lot, and a quality hold is not recommended for the lot.This product is manufactured for pfizer by icu medical #.As pfizer is the application holder for this product, the decision regarding a quality hold will be determined by pfizer.Follow-up (09dec2021): this is a follow-up spontaneous report from a product quality complaint group.Updated information: investigation results.No follow-up attempts are needed.No further information is expected.Follow-up (15dec2021, 16dec2021): this is a spontaneous follow up report received from a contactable pharmacist.This is a follow-up report from product quality group providing investigation results.Updated information: product indication, dose strength, action taken, investigation results.No follow-up attempts are needed.No further information is expected.

Manufacturer Narrative

The complaint for "plug remained so the product could not be diluted or mixed" for lot 15101dd and parent lot 15100dd was investigated.The investigation included reviewing incoming quality and an analysis of the complaint history for the reported product type.This product is filled, labeled, and packaged by pfizer mcpherson.The final scope was determined to be 15101dd and parent lot 15100dd.No quality issue were identified during the investigation.There is no impact to the product.An ntm was not issued for the current complaint.An mdr has been filed.Per the related mdcp record (b))(4): this is medical device related.The complaint condition was not confirmed; therefore, the root cause could not be determined as manufacture or vendor related.No corrective or preventative actions were identified, the complaint was not attributed to the manufacturing processes.There are controls currently in place are sufficient for preventing and removing defective units prior to product release.Return sample evaluation: on 29nov2021 the sample was received, documented, and photographed by complaint specialist (b)(4).The sample consisted of one flexible sodium chloride container, lot 4772109, attached to one vial of diltiazem lot 15101dd.The inner cap and o-ring had been removed from the drug vial-vial port assembly but the rubber stopper was still seated in the drug vial.Using add-vantage instructions, the complaint specialist manipulated the inner cap and the o-ring back into the drug vial- vial port assembly.The inner cap and o-ring were then pulled from the drug vial-vial port assembly, successfully removing the rubber stopper and activating the drug vial.No defect was confirmed in the returned customer sample.No further analysis is warranted.

• Brand Name: ADD-VANTAGE ADDAPTOR
• Type of Device: DEVICE DELIVERY AID; CLASS II
• Manufacturer (Section D): PFIZER, INC. (DEVICE); 7000 portage road; kalamazoo MI 49001
• Manufacturer (Section G): PFIZER, INC. (DEVICE); 7000 portage road; kalamazoo MI 49001
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017 ; 2127334045
• MDR Report Key: 12882613
• MDR Text Key: 285769396
• Report Number: 1810189-2021-00029
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2022
• Device Lot Number: 4772109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female