MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC SET 2-L: 5.5 FR X 55 CM; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-45552-HP
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported when the rn began to peel away the sheath, part of the sheath broke off from the bottom portion of the sheath.The sheath was removed in its entirety from the patient and nothing was left behind.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The complaint of a peel-away sheath torn incorrectly was able to be confirmed by the photo.The customer also returned one peel-away sheath for evaluation.Signs of use were observed.Visual inspection of the peel-away sheath revealed that it was not torn along the score lines as intended.A segment of the peel-away sheath was completely separated.The separation points were stretched and jagged.Upon further inspection of the product bill of materials (bom), it was observed that the reported finished good does not contain the returned peel-away sheath, but rather a different, purchased peel-away sheath.It cannot be confirmed whether the customer returned the wrong device or whether the wrong finished good part number was reported.Functional inspection could not be accurately performed due to the condition of the returned sample.A device history record review was performed, and no relevant findings were identified.The customer report of a peel-away sheath torn incorrectly was confirmed through complaint investigation of the returned sample.Visual inspection revealed the sheath did not tear along the score lines; however, further inspection of the reported product bill of materials revealed the reported part number does not contain the returned sheath.Therefore, either the wrong device was returned, or the wrong part number was reported by the customer.A device history record review was performed on the reported sheath with no relevant findings.Based on the discrepancy between the reported finished good and the returned device, the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported when the rn began to peel away the sheath, part of the sheath broke off from the bottom portion of the sheath.The sheath was removed in its entirety from the patient and nothing was left behind.The patient's condition is reported as fine.

• Brand Name: ARROW AM PICC SET 2-L: 5.5 FR X 55 CM
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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: 17607144
• Report Number: 9680794-2023-00604
• Device Sequence Number: 12328085
• Product Code: LJS
• UDI-Device Identifier: 20801902095767
• UDI-Public: 20801902095767
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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: 04/19/2024
• Device Catalogue Number: PR-45552-HP
• Device Lot Number: 14F22E0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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