MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA KIT: 5.5 FR X 55 CM; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN056682
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the hub fell off the extension line.The patient had fallen off the x-ray table and the catheter "stretched like a rubber band".The catheter had 2 cm out before the incident and still only had 2cm out after the stretch from the fall, so the catheter did not change position.It stretched the extension line.Later the staff was repositioning the patient in his bed and the catheter got hung up in the bedrail.It was at that point the hub separated from the extension line.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-lumen picc for investigation.Evidence of use was observed and the catheter body appeared to be intentionally cut.Visual inspection revealed the distal extension line had separated from its luer hub.Remains of the extension line were visible inside the luer hub.The total length of the catheter body measured to be 17" which is not within the specification of 22.75" - 23" per product drawing.This indicates that at least 5.75" of the catheter were cut and not returned for analysis.The outer diameter of the distal lumen measured to be 0.0950" which is within specifications of 0.093" - 0.097" per product drawing.The inner diameter of the distal lumen measured to be 0.057" which is within specifications of 0.055" - 0.059" per product drawing.This indicates that the wall thickness measured within specifications.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit instructs the user, "attach pre-filled saline syringe, if provided, or other syringe to sidearm and flush distal lumen with sterile saline solution.Leave syringe in place.Flush remaining lumen(s) with sterile saline.Clamp or attach injection site cap(s) to extension line(s) to contain saline within lumen." the proximal extension line flushed as expected.No leaks or blockages were observed.A manual tug test confirmed the proximal lumen was fully secured to its luer hub.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the complaint of an extension line/luer hub separation was confirmed through a complaint investigation on the returned sample.The distal extension line was separated from its hub.The returned sample passed all relevant dimensional inspections.A device history record review was performed, and no relevant findings were identified.The type of damage observed is consistent with a manufacturing issue in the picc lines.A non-conformance has been initiated to further investigate this issue.
Event or Problem Description
It was reported the hub fell off the extension line.The patient had fallen off the x-ray table and the catheter "stretched like a rubber band".The catheter had 2 cm out before the incident and still only had 2cm out after the stretch from the fall, so the catheter did not change position.It stretched the extension line.Later the staff was repositioning the patient in his bed and the catheter got hung up in the bedrail.It was at that point the hub separated from the extension line.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 5.5 FR X 55 CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13397816
• Report Number: 9680794-2022-00044
• Device Sequence Number: 4382950
• Product Code: LJS
• UDI-Device Identifier: 10801902167719
• UDI-Public: 10801902167719
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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
• Device Expiration Date: 06/30/2023
• Device Model Number: IPN056682
• Device Catalogue Number: ASK-45552-MHBV
• Device Lot Number: 13F21L0300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown