MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LAP SPONGE IN PACK BASIC PLASTIC CHRG

Catalog Number DYNJ60227A

Device Problem Break (1069)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that, during a breast reconstruction procedure, a lap sponge string "came apart" from the lap sponge as it was being "pulled from the cavity" by the surgeon.The lap sponge string fell back into the surgical site.The surgeon retrieved the lap sponge string by hand with no further incident reported.According to the reporting facility, there was no adverse impact to the patient.No sample evaluation is available at this time.Due to the reported need for medical intervention to retrieve the lap sponge string from the surgical site, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a lap sponge string "came apart" from the lap sponge and fell back into the surgical site.

Manufacturer Narrative

A photo and a sample of the lap sponge were received by the manufacturer with investigation completed on 19-apr-2021.Physical inspection of the received sample found that the indicator string of the lap sponge was not attached and that it did not appear to be initially sewn in.No other physical damage was noted on the received sample.A root cause was unable to be determined with the received sample.If additional relevant information becomes available another supplemental medwatch will be filed.

• Type of Device: LAP SPONGE IN PACK BASIC PLASTIC CHRG
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11686636
• MDR Text Key: 248442805
• Report Number: 1423395-2021-00020
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 10193489246247
• UDI-Public: 10193489246247
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ60227A
• Device Lot Number: 20LMF564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention