MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; NMSA LAP CHOLE PACK

Catalog Number	DYNJ65061A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fever (1858); Pain (1994); Foreign Body In Patient (2687)
Date of Event	09/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 during a local injection the needle broke off at the hub and remained in the patient.The customer reported the patient spent "45 additional minutes" in the operating room while the surgeon attempted to find the needle "manually and with imaging" but, was not able to retrieve the needle.The customer reported when the patient was seen in the outpatient setting after surgery, the patient experienced "redness/fever" and reported the needle causing discomfort.The customer reported the patient required an additional surgery to remove the needle on (b)(6) 2023.Sample requested for return 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 or Problem Description
According to the customer, on (b)(6) 2023 during a local injection the needle broke off at the hub and remained in the patient.

• Common Device Name: NMSA LAP CHOLE 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: 18069744
• Report Number: 1423395-2023-00069
• Device Sequence Number: 7665626
• Product Code: FDE
• UDI-Device Identifier: 10193489856637
• UDI-Public: 10193489856637
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ65061A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown