MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LAPAROTOMY PACK

Catalog Number DYNJ60868

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Information (3190)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

It was initially reported that during an unidentified procedure, "small blue fuzz" was found on the patient's bowel.Despite good faith efforts to obtain additional information, no further patient, product, procedural or event details are available.It is unknown what component from the custom surgical pack was the source of the reported "small blue fuzz." due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that during an unidentified procedure, "small blue fuzz" was found on the patient's bowel.

• Type of Device: LAPAROTOMY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 9273364
• MDR Text Key: 190758832
• Report Number: 1423395-2019-00046
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ60868
• Device Lot Number: 19HBO552
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other