MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC: 2-L 5FR X 40CM W/ 80CM HYDRO NI; CATHETER, INTRAVASCULAR, THER

Catalog Number PR-34052-HPHNM

Device Problem Contamination (1120)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported there was "hair on the product after opening it up".The issue was detected prior to patient use.No patient involvement.

Manufacturer Narrative

(b)(6).The customer returned one photo for evaluation.The photo revealed a hair on a dilator/sheath assembly.The customer returned one opened picc set for evaluation.Visual inspection of the kit revealed there was one hair on top of the kit as well as one hair stuck in-between the dilator and sheath.A device history record review was performed and no relevant findings were identified.The complaint of a hair in a device was confirmed by a complaint investigation of the returned sample and visual inspection of the c ustomer photo.A hair was found in-between the dilator and sheath assembly.Based on the sample returned, manufacturing caused or contributed to this issue.A non-conformance was initiated for this complaint investigation.Teleflex will continue to monitor and trend on complaint of this nature.

Event Description

It was reported there was "hair on the product after opening it up".The issue was detected prior to patient use.No patient involvement.

• Brand Name: ARROW PI PICC: 2-L 5FR X 40CM W/ 80CM HYDRO NI
• Type of Device: 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: 15031351
• MDR Text Key: 304345220
• Report Number: 9680794-2022-00471
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: PR-34052-HPHNM
• Device Lot Number: 13F21F0362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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