MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; NEEDLE IN LAP CHOLE PACK

Catalog Number	DYNJ37010F
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the gauge 25 (1.5 inches) needle broke off into patient while injecting bupivacaine (local anesthetic) into the patient's right peri-umbilical region.During inspection prior to use, it was denied that there were any signs of mishandling noted with the needle.The needle's shaft reportedly broke from the hub and the broken needle went from the umbilicus to the psoas muscle (lower lumbar region), requiring a hospital stay and another procedure.Per report, the next day, the patient underwent ct directed percutaneous retrieval of the retained needle.It was reported that the patient was stable and was discharged to home the day after the incident.Due to the reported event and medical intervention required to retrieve the broken needle, this medwatch is being filed.A companion sample had been returned for evaluation and the complaint was confirmed.A definitive root cause could not be determined at this time.No additional information is available.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the gauge 25 (1.5 inches) needle broke off into patient while injecting local anesthetic into the patient's right peri-umbilical region.

• Common Device Name: NEEDLE IN LAP CHOLE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8664540
• Report Number: 1423395-2019-00018
• Device Sequence Number: 2118021
• Product Code: FDE
• UDI-Device Identifier: 10889942737895
• UDI-Public: 10889942737895
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/03/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ37010F
• Device Lot Number: 18KBE366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 31 YR