MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED

Model Number IPN000083

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

There was no patient involvement.It was reported that procurement noticed a hole in the external packaging on one of the product during stocking.

Event Description

There was no patient involvement.It was reported that procurement noticed a hole in the external packaging on one of the product during stocking.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint that the "pouch has hole/tear" is confirmed.Upon visual inspection, a tear was noted on the original packaging pouch.No other damage was noted to the packaging.No visual or functional abnormalities were noted to the returned catheter.The root cause of the complaint is undetermined.A potential cause is customer handling.This complaint is considered isolated.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

• Brand Name: CATH PKGD: BERMAN 5 FR 80CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10705333
• MDR Text Key: 212107233
• Report Number: 3010532612-2020-00313
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002273
• UDI-Public: 00801902002273
• Combination Product (y/n): N
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: IPN000083
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F20D0061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1