MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037306
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: getting ready to put dressing on.Bbe (blue bullseye) obtained.Flushed picc, after flush pt complained of nausea.Rn attempted to finish case.Got unsterile/jiggled wires to make sure the case printed.Pt became diaphoretic and vital signs were abnormal.Picc removed and chest xray performed.Tachycardic, pt complained of blurred vision.Physician suspected air embolism.Pt indicated throat felt swollen.It was reported there was no air embolism and chg (chlorhexidine) was added as an allergy for the patient.The patient was treated with benadryl and steroids.The patient has been discharged from the hospital and is doing fine.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The agba insert provided in this kit states, "the arrowg+ard blue advance antimicrobial/anti-thrombogenic catheter is contraindicated for patients with known hypersensitivity to chlorhexidine." the card also instructs, "perform sensitivity testing to confirm allergy to catheter antimicrobial agents if adverse reaction occurs." the customer report of an allergic reaction was confirmed by the event details of the reported complaint.The patient had an allergic reaction and later was confirmed to have a chlorhexidine allergy.Chlorhexidine is included in the coating of the catheter in this kit.A device history record review was performed on a potential lot identified from sales history.No relevant findings were identified to suggest a manufacturing related issue.Based on the information provided, unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
The complaint is reported as: getting ready to put dressing on.Bbe (blue bullseye) obtained.Flushed picc, after flush pt complained of nausea.Rn attempted to finish case.Got unsterile/jiggled wires to make sure the case printed.Pt became diaphoretic and vital signs were abnormal.Picc removed and chest xray performed.Tachycardic, pt complained of blurred vision.Physician suspected air embolism.Pt indicated throat felt swollen.It was reported there was no air embolism and chg (chlorhexidine) was added as an allergy for the patient.The patient was treated with benadryl and steroids.The patient has been discharged from the hospital and is doing fine.
Event or Problem Description
The complaint is reported as: getting ready to put dressing on.Bbe (blue bullseye) obtained.Flushed picc, after flush pt complained of nausea.Rn attempted to finish case.Got unsterile/jiggled wires to make sure the case printed.Pt became diaphoretic and vital signs were abnormal.Picc removed and chest xray performed.Tachycardic, pt complained of blurred vision.Physician suspected air embolism.Pt indicated throat felt swollen.It was reported there was no air embolism and chg (chlorhexidine) was added as an allergy for the patient.The patient was treated with benadryl and steroids.The patient has been discharged from the hospital and is doing fine.
Additional Manufacturer Narrative
Qn#: (b)(4).The customer returned one single-lumen picc for evaluation.The catheter body appeared to be intentionally trimmed and signs of use were found in the extension line.Visual examination of the catheter did not reveal any defects or anomalies.The catheter coating appeared typical with no discoloration.The total length of the catheter body measured to be 16.14" which indicates at least 5.49" were trimmed and not returned per product drawing.The returned sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs, "attach pre-filled saline syringe, if provided, or other syringe to sidearm and flush distal lumen with sterile saline solution.Leave syringe in place."the returned catheter was flushed using a lab inventory syringe to ensure no blockages were present.The catheter flushed as expected.The distal end of the catheter was occluded and the extension line was pressurized using a water-filled lab inventory syringe.No leaks were detected.Additional testing of the catheter coating could not be performed as the catheter was inserted into the patient.Once the catheter is inserted, the coating begins releasing into the bloodstream.A device history record review was performed with no relevant findings.The agba insert provided in this kit states, "the arrowg+ard blue advance antimicrobial/antithrombogenic catheter is contraindicated for patients with known hypersensitivity to chlorhexidine." the card also instructs, "perform sensitivity testing to confirm allergy to catheter antimicrobial agents if adverse reaction occurs." the customer report of an allergic reaction was confirmed by the event details of the reported complaint.The patient had an allergic reaction and later was confirmed to have a chlorhexidine allergy.Chlorhexidine is included in the coating of the catheter in this kit.A device history record review was performed with no relevant findings were identified to suggest a manufacturing related issue.The returned catheter passed all relevant visual and functional testing.Based on the information provided, unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12213079
• Report Number: 9680794-2021-00359
• Device Sequence Number: 11908662
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: 50801902120781
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: IPN037306
• Device Catalogue Number: CDC-45541-VPS2
• Device Lot Number: 13F21B0418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 08/12/2021; 08/24/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/13/2021; 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.; N/A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 102