MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; HYPODERMIC NEEDLE IN MAJOR ABD PACK

Catalog Number DYNJ01223G

Device Problem Break (1069)

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

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a radical vulvectomy, the 25 gauge x 1.5 inches needle (from custom surgical tray) was being used to inject local anesthesia and the needle broke into the surgical site.Reportedly, it is "not sure" if excessive force was applied to or against the needle.During inspection prior to use, there were reportedly no issues noted with the needle at that time.The needle that broke off into the surgical site was successfully retrieved through use of forceps.The patient was reportedly moved to a different room with c-arm.The patient is reportedly doing well at this time.Due to the reported incident of needle breaking off into the surgical site and the medical intervention required to retrieve the broken needle, this medwatch is being filed.The sample is not available to be returned for evaluation.A definitive root cause for the reported issue could not be determined.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the 25 gauge x 1.5 inches needle (from custom surgical tray) was being used to inject local anesthesia and the needle broke into the surgical site.

• Type of Device: HYPODERMIC NEEDLE IN MAJOR ABD 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: 9261355
• MDR Text Key: 190758082
• Report Number: 1423395-2019-00044
• Device Sequence Number: 1
• Product Code: LRO
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ01223G
• Device Lot Number: 19EDB873
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/31/2019
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 111