MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; GENERAL DERM SURGERY TRAY

Catalog Number MNS13445

Device Problem Connection Problem (2900)

Patient Problem Laceration(s) (1946)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer contact, on (b)(6) 2023 a nurse was setting up for a procedure.She was putting a different blade (bard parker) on the medline handle.The customer reports the blade was not locking into the handle and it slipped causing her to cut the right dorsal index and middle fingers.The incident resulted in the nurse requiring sutures.The customer reported the sutures have been removed and she has full use of her fingers at this time.A sample has been 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

Cut requiring sutures.

• Type of Device: GENERAL DERM SURGERY TRAY
• 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: 16541781
• MDR Text Key: 311289699
• Report Number: 1417592-2023-00102
• Device Sequence Number: 1
• Product Code: LRO
• 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: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MNS13445
• Device Lot Number: 21KBN779
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other