MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO NI; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN914853
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the picc line was inserted under normal conditions in radiology with no complication.When the radiologist attempted to peel the sheath off the catheter, the peel-away sheath was difficult to remove from the catheter and snapped into two parts.They checked the two lengths to ensure no plastic from the broken sheath was left inside the patient.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer did not return a complaint sample; however, they supplied two photos showing a peel-away catheter and a sticker label.Visual analysis revealed that a portion of the peel-away had separated from the extrusion.It was also noted that the peel-away sheath was split completely down the score line.A device history record review was performed, and a relevant finding was identified.Non-conformances were initiated for batches 34c20e0216 and 34c20g0295 to address the issue of a peel-away sheath tearing incorrectly.The ifu provided with the kit informs the user, "grasp tabs of peel-away sheath and pull apart, away from catheter, while withdrawing from vessel until sheath splits down its entire length".Based on the customer report , the customer supplied images, and the relevant findings in the dhr, it was determined that manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the picc line was inserted under normal conditions in radiology with no complication.When the radiologist attempted to peel the sheath off the catheter, the peel-away sheath was difficult to remove from the catheter and snapped into two parts.They checked the two lengths to ensure no plastic from the broken sheath was left inside the patient.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO NI
• 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: 13402726
• Report Number: 9680794-2022-00053
• Device Sequence Number: 4999043
• Product Code: LJS
• UDI-Device Identifier: 10801902158755
• UDI-Public: 10801902158755
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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: 04/30/2023
• Device Model Number: IPN914853
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 13F21E0600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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: N/A.; N/A.
• Patient Sex: Unknown