MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; 25G NEEDLE IN AUGMENTATION PACK

Catalog Number DYNJ43564B

Device Problems Break (1069); Device Fell (4014)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that, during an unidentified procedure, the 25g needle "broke off at the hub" and fell into the patient's incision site.Despite multiple good-faith attempts the reporting facility was unable or unwilling to provide additional patient, product, or procedural information related to this report.The reporting facility originally reported that, at the time of the incident, an x-ray was utilized to locate the broken 25g needle piece and that it was successfully retrieved from the incision site.No further incident was originally reported.No adverse patient impact was originally reported.Of note, the reporting facility originally indicated that they were unsure if the 25g needle involved in the reported incident was manufactured by medline industries, inc.Or becton, dickson and company (bd).No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention to locate and retrieved the broken 25g needle piece from the incision site, 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 25g needle "broke off at the hub" and fell into the patient's incision site.

Event Description

It was reported that the 25g needle "broke off at the hub" and fell into the patient's incision site.

Manufacturer Narrative

The manufacturer received additional information from the reporting facility.It was reported that the 25g needle break occurred during a bilateral augmentation mammoplasty.Use of the 25g needle at the time of the incident was not identified.The broken piece fell into the patient's incision site and could not be visualized by the surgeon for retrieval.An x-ray machine was brought into the procedure and used to locate the broken piece.The broken piece was able to be located and successfully retrieved under fluoroscopy guidance.The patient was reportedly under general anesthesia at the time of the incident and a "minimal" amount of additional anesthesia was administered during retrieval of the broken piece.No further incident was reported.No adverse patient impact was reported.A sample has not be returned to the manufacturer.If additional relevant information becomes available another supplemental medwatch will be filed.

• Type of Device: 25G NEEDLE IN AUGMENTATION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9427149
• MDR Text Key: 190758939
• Report Number: 1423395-2019-00048
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ43564B
• Device Lot Number: 19FBO898
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Weight: 59