MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; GAUZE IN LAPAROSCOPY PACK

Catalog Number DYNJ60867

Device Problem Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during an unidentified procedure the gauze unraveled while inside of a patient's abdomen.The gauze was reportedly removed with no harm to the patient.Despite multiple good-faith attempts, the reporting facility was unable or unwilling to provide additional patient, product, or procedural information to the manufacturer.The use of the gauze during the unidentified procedure is unknown.No impact or adverse effect to the patient or to the unidentified procedure was originally reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the gauze unraveled while inside of a patient.

• Type of Device: GAUZE IN LAPAROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 8930857
• MDR Text Key: 162645400
• Report Number: 1423395-2019-00030
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10193489663099
• UDI-Public: 10193489663099
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ60867
• Device Lot Number: 19EBU517
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/26/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention