MAUDE Adverse Event Report: TELEFLEX MEDICAL EXTRACTION BAG FOR MIS

Catalog Number 332800-000010

Device Problem Material Disintegration (1177)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is not available for investigation.The manufacturer will continue to monitor and trend related events.

Event Description

While pulling out the bladder, some white particles coming from the purse line fell out and were deposited inside the patient's abdomen.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product visistat 35w non-sterile, lot # 73b1600319 was manufactured on 02/15/2016 a total of (b)(4) pieces.Lot was released on 02/18/2016.Dhr investigation did not show issues related to complaint.Additional test performed as follows: the 13 samples were taken from the current production (visistat 35w) lot # 73k1600249, the samples were functionally tested according with the characteristics in the procedure qip-0031 tecrev21, and issue reported "stuck in stapler" was not present in the current manufacturing process.Per dhr the product visistat 35w non-sterile, lot # 73b1600319 was manufactured on 02/15/2016 a total of (b)(4) pieces.Lot was released on 02/18/2016.Dhr investigation did not show issues related to complaint.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

Event Description

While pulling out the bladder, some white particles coming from the purse line fell out and were deposited inside the patient's abdomen.The patient's condition was reported as fine.

• Brand Name: EXTRACTION BAG FOR MIS
• 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: 5947469
• MDR Text Key: 55154267
• Report Number: 3006425876-2016-00276
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 332800-000010
• Device Lot Number: 71F16D0612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1