MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; NEURO PACK

Catalog Number DYNJ45320I

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

It was reported that the plastic piece fell off the tip of the pencil into the wound and was removed without incident by the surgeon.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

Tip fell off into wound.

• Type of Device: NEURO PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield, il 60093 ; MX 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19078681
• MDR Text Key: 339811404
• Report Number: 1423395-2024-00390
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10195327242282
• UDI-Public: 10195327242282
• 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: 04/10/2024

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: DYNJ45320I
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/10/2024
• 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