MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; C-SECTION TRAY 7BOB

Catalog Number MNS13820

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that "inadvertent puncture of uterine arteries during closure because the needle rotates freely".A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

"inadvertent puncture of uterine arteries".

• Type of Device: C-SECTION TRAY 7BOB
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18222452
• MDR Text Key: 329193208
• Report Number: 1417592-2023-00470
• Device Sequence Number: 1
• Product Code: OHM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MNS13820
• Device Lot Number: 23HBK064
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other