MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SPINE PACK

Catalog Number DYNJ24261G

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

It was reported that on 02/27/2024 when injecting "local from the syringe" the wing broke off cutting the surgeon's thumb.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that on 02/27/2024 when injecting "local from the syringe" the wing broke off cutting the surgeon's thumb.

• Type of Device: SPINE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19003840
• MDR Text Key: 339208940
• Report Number: 1423395-2024-00374
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 40195327224494
• UDI-Public: 40195327224494
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ24261G
• Device Lot Number: 23KBH614
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other