MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SMARTSITE¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20038E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set was blocked during the flush and when trying to deliver pitocin during the infusion.The following information was provided by the initial reporter: "i have found that when i go to flush the 3 prong iv attachment, 1 of the ports sometimes do not flush at all no matter how much force used (and i'm referring to straight out of the package before it is ever connected to the patient).Tonight one of the nurses came out her rooms after delivery asking for help because her pitocin was not running into the patient at all after delivery.I tried flushing the line for her and was met with a lot of resistance and was unable to flush.I then tried removing the pitocin from one of the 3 prongs which it was on and was unable to flush from further down as well.It then "clicked" that maybe this was one of the defective 3 prong iv connectors, so i switched the iv line to the main port and the fluids ran nicely.".
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set was blocked during the flush and when trying to deliver pitocin during the infusion.This occurred in an unspecified lot with 3 - 5 sets, and one set from lot 23055439.The following information was provided by the initial reporter: "i have found that when i go to flush the 3 prong iv attachment, 1 of the ports sometimes do not flush at all no matter how much force used (and i'm referring to straight out of the package before it is ever connected to the patient).Tonight one of the nurses came out her rooms after delivery asking for help because her pitocin was not running into the patient at all after delivery.I tried flushing the line for her and was met with a lot of resistance and was unable to flush.I then tried removing the pitocin from one of the 3 prongs which it was on and was unable to flush from further down as well.It then "clicked" that maybe this was one of the defective 3 prong iv connectors, so i switched the iv line to the main port and the fluids ran nicely.Additional info from customer: (07-aug-2023) is there any adverse event occurred? no what is the total number of occurrences? 3-5 approximately can you identify the batch number? unsure is there any leakage issue? no.Just unable to flush and infuse fluids through properly.".
Additional Manufacturer Narrative
The following fields have been updated with additional information: b.5.Describe event or problem: it was reported that the bd alaris¿ smartsite¿ extension set was blocked during the flush and when trying to deliver pitocin during the infusion.This occurred in an unspecified lot with 3 - 5 sets, and one set from lot 23055439.The following information was provided by the initial reporter: "i have found that when i go to flush the 3 prong iv attachment, 1 of the ports sometimes do not flush at all no matter how much force used (and i'm referring to straight out of the package before it is ever connected to the patient).Tonight one of the nurses came out her rooms after delivery asking for help because her pitocin was not running into the patient at all after delivery.I tried flushing the line for her and was met with a lot of resistance and was unable to flush.I then tried removing the pitocin from one of the 3 prongs which it was on and was unable to flush from further down as well.It then "clicked" that maybe this was one of the defective 3 prong iv connectors, so i switched the iv line to the main port and the fluids ran nicely.Additional info from customer: (07-aug-2023) is there any adverse event occurred? no what is the total number of occurrences? 3-5 approximately can you identify the batch number? unsure is there any leakage issue? no.Just unable to flush and infuse fluids through properly." there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 23055439.D.4.Medical device expiration date: 20-may-2026.H.4.Device manufacture date: 19-may-2023.D.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.D.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 09-aug-2023.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set was blocked during the flush and when trying to deliver pitocin during the infusion.This occurred in an unspecified lot with 3 - 5 sets, and one set from lot 23055439.The following information was provided by the initial reporter: "i have found that when i go to flush the 3 prong iv attachment, 1 of the ports sometimes do not flush at all no matter how much force used (and i'm referring to straight out of the package before it is ever connected to the patient).Tonight one of the nurses came out her rooms after delivery asking for help because her pitocin was not running into the patient at all after delivery.I tried flushing the line for her and was met with a lot of resistance and was unable to flush.I then tried removing the pitocin from one of the 3 prongs which it was on and was unable to flush from further down as well.It then "clicked" that maybe this was one of the defective 3 prong iv connectors, so i switched the iv line to the main port and the fluids ran nicely.Additional info from customer: (07-aug-2023).Is there any adverse event occurred? no.What is the total number of occurrences? 3-5 approximately.Can you identify the batch number? unsure.Is there any leakage issue? no.Just unable to flush and infuse fluids through properly.".
Additional Manufacturer Narrative
One sample model 20038e lot 23055439 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a 10 ml bd syringe filled with water.The set was able to be flushed.The customer complaint that the set was unable to be flushed was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 20038e lot number 23055439 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.

• Brand Name: BD ALARIS¿ SMARTSITE¿ EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17507455
• Report Number: 9616066-2023-01722
• Device Sequence Number: 6387792
• Product Code: FPA
• UDI-Device Identifier: 07613203011976
• UDI-Public: 07613203011976
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 20038E
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 09/20/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/05/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown