MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN035447
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: during maintenance of an inpatient, staff on unit discovered that hub of the distal lumen was no longer attached to picc line.No patient injury or consequence reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-l picc for investigation.Signs of use in the form of biological material were present on the catheter.Visual inspection revealed the distal luer hub was separated from the distal extension line and not returned.The edges of separation were rough and jagged, indicating a stress-related tear.Visual examination of the distal luer hub could not be performed as it was not returned for analysis.The total length of the returned catheter body measured 555 mm which is within specifications of 546-558.8 mm per product drawing.The outer diameter of the distal extension line measured 0.093" which is within specifications of 0.093" - 0.097" per distal extrusion graphic.The inner diameter of the distal extension line measured 0.057" which is within specifications of 0.055" - 0.059" per distal extrusion graphic.This indicates that the wall thickness measured within specifications.The proximal extension line was flushed per ifu which states, "flush lumen(s) to completely clear blood from catheter." the lumen flushed as expected.A manual tug test confirmed the proximal extension line was fully secured within the luer hub.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested.The report of an extension line/luer hub separation was confirmed through the complaint investigation.Visual analysis revealed that the distal extension line had separated adjacent to the luer hub; however, the separated luer hub was not returned.The catheter and the distal extension line met all relevant dimensional requirements and a device history record review did not reveal any relevant findings.Without the luer hub , the root cause of this complaint could not be determined.Teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
The complaint is reported as: during maintenance of an inpatient, staff on unit discovered that hub of the distal lumen was no longer attached to picc line.No patient injury or consequence reported.The patient's condition is reported as fine.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12280012
• Report Number: 9680794-2021-00386
• Device Sequence Number: 4507344
• Product Code: LJS
• UDI-Device Identifier: 30801902134609
• UDI-Public: 30801902134609
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: No Information
• Device Expiration Date: 07/31/2022
• Device Model Number: IPN035447
• Device Catalogue Number: CDA-45552-VPS2
• Device Lot Number: 13R20M0328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1