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

Catalog Number DYNJ65061A

Device Problem Break (1069)

Patient Problems Fever (1858); Pain (1994); Foreign Body In Patient (2687)

Event Date 09/16/2023

Event Type  Injury  

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 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.

• Type of Device: 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
• MDR Text Key: 327351728
• Report Number: 1423395-2023-00069
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10193489856637
• UDI-Public: 10193489856637
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ65061A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2023
• 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