MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS; INTRODUCER, CATHETER

Model Number	IPN037307
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported "port snapped off" while proning a patient.No patient harm reported.The catheter was replaced.The patient's condition is reported as fine.
Event or Problem Description
Customer reported "port snapped off" while proning a patient.No patient harm reported.The catheter was replaced.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one picc catheter for analysis.Signs-of-use in the form of biological material was observed on the catheter body.The catheter body was intentionally severed directly below the 44cm mark.The severed portion was not returned for analysis.Additionally, the severed proximal luer hub was also not returned for analysis.Visual analysis revealed that the proximal extension line luer hub had separated from the catheter and was not returned for analysis.Because the separated luer hub was not returned, it cannot be determined if a portion of the extension line was still inside the luer hub.The catheter body length from the juncture hub to the point of separation measured 17 7/8".This indicates that 3 5/8"- 4 1/4" of the catheter body was severed and not returned for analysis (per catheter graphic).The proximal extension line outer diameter measured.094" which is within the specification limits of.093"-.097" per the proximal extension line extrusion graphic.The proximal extension line inner diameter measured.055" which is within the specification limits of.055"-.059" per the proximal extension line extrusion graphic.A manual tug test confirmed that the proximal and medial luer hubs were secure to their respective extension lines.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 a separated extension line was confirmed through complaint investigation.Visual analysis revealed that the proximal extension line luer hub had separated from the catheter and was not returned.The catheter met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, the root cause cannot be determined without the separated proximal luer hub returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12478837
• Report Number: 9680794-2021-00458
• Device Sequence Number: 3821869
• Product Code: DYB
• UDI-Device Identifier: 50801902120811
• UDI-Public: 50801902120811
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 08/30/2021

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: IPN037307
• Device Catalogue Number: CDC-45563-VPS2
• Device Lot Number: 13F21B0467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/12/2021
• 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: NOT REPORTED.; NOT REPORTED.; NOT REPORTED.