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

Catalog Number DYNJ37010F

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/08/2019

Event Type  Injury  

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 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.

• Type of Device: NEEDLE IN LAP CHOLE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8664540
• MDR Text Key: 146907630
• Report Number: 1423395-2019-00018
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10889942737895
• UDI-Public: 10889942737895
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ37010F
• Device Lot Number: 18KBE366
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR