MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC: 2-L 5FR X 40CM 80CM HNIT WIRE; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number PR-34052-NM

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported on (b)(6) 2022, that the user couldn't tear tabs of the peel-away sheath correctly.Therefore, a new unit was used instead.No medical intervention was needed, and no patient injury was reported.

Event Description

It was reported on (b)(6) 2022, that the user couldn't tear tabs of the peel-away sheath correctly.Therefore, a new unit was used instead.No medical intervention was needed, and no patient injury was reported.

Manufacturer Narrative

(b)(4).The customer returned one peel-away sheath and dilator for investigation.Signs of use in the form of biological material were observed on the sheath.Visual examination revealed one sheath tab was separated from the sheath body.A portion of the sheath body remained within the hub.The separation points appeared stretched and jagged.It was observed that the sheath did not fully tear along the score lines.One blue score line was partially separated/torn.The total length of the sheath body measured to be 2 3/4" which is within the specifications of 2 5/8"-2 7/8" per product drawing.The sheath outer diameter measured 0.09564", which is within the specification limits of 0.093"-0.099" per product drawing.The sheath inner diameter could not be accurately measured due to the damage.A manual tug test confirmed the remaining tab was fully secured to the sheath body.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit instructs the user, "grasp tabs of peel-away sheath and pull apart, away from the catheter, while withdrawing from vessel (refer to figure 6) until sheath splits down its entire length." the report of a peel-away sheath tearing incorrectly was confirmed through complaint investigation.Visual examination revealed one sheath tab was separated from the sheath extrusion.The sheath met all relevant dimensional requirements.The appearance of the defect seems consistent with damage that occurred during the manufacturing process.Based on the customer report and the sample received, 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.

• Brand Name: ARROW PI PICC: 2-L 5FR X 40CM 80CM HNIT WIRE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• 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: 15523327
• MDR Text Key: 306361350
• Report Number: 9680794-2022-00623
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: PR-34052-NM
• Device Lot Number: 13F21K0632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1