MAUDE Adverse Event Report: TELEFLEX MEDICAL EXTRACTION BAG FOR MIS; BAG, INTESTINE

Model Number IPN004942

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2022

Event Type  malfunction  

Event Description

The bag tore during the use.

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.

Manufacturer Narrative

(b)(4).Customer complaint regarding memobag product was reported.As the lot number of the defective product was reported, the dhr review was completed.The review of ohr revealed no production issues at the time of manufacture of the complained lot.The defective device was returned for examination.Defect (bag torn) can be confirmed based on visual inspection.One hole/rupture was found in the bottom part of memobag.The defect was caused by use of excessive force within bag retrieval.Due to this the foil got stretched which led to the rupture of the bag in foil wall.Other parts of complained product do not show any traces corresponding with usage of excessive force within retrieving the bag.The closure wire was not detached from the bag and both eyes of closure wire are not damaged.As the root cause of this complaint was determined unintentional user error related, no corrective/preventive actions in production are deemed necessary to introduce.

Event Description

The bag tore during the use.

• Brand Name: EXTRACTION BAG FOR MIS
• Type of Device: BAG, INTESTINE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15103125
• MDR Text Key: 300367574
• Report Number: 3006425876-2022-00703
• Device Sequence Number: 1
• Product Code: KGY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN004942
• Device Catalogue Number: 332801-000020
• Device Lot Number: 71F20K0445
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1