MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; HYPODERMIC NEEDLE IN UNIVERSAL LAPAROSCOPY PACK-LF

Catalog Number DYNJ0696288I

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the hypodermic needle detached from the hub and became lodged in a patient's subcutaneous (subq) abdominal tissue.Despite multiple good faith attempts the reporting facility was unable or unwilling to provide additional information to the manufacturer.It is unknown how the hypodermic needle was being used at the time of the incident and how/if the detached hypodermic needle was retrieved from the patient's subq abdominal tissue.No additional information was provided and no sample was returned to the manufacturer.A root cause for the reported incident was unable to be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the hypodermic needle detached from the hub.

• Type of Device: HYPODERMIC NEEDLE IN UNIVERSAL LAPAROSCOPY PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, il ; 9311458
• MDR Report Key: 9714536
• MDR Text Key: 190751555
• Report Number: 1423395-2020-00002
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ0696288I
• Device Lot Number: 19JKC148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• 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