MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; LAPAROSCOPY GYN PACK-LF

Catalog Number DYNJV0262J

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/04/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2022 while administering 0.5% bupivacaine with epinephrine intradermally the shaft of a 25 gauge needle separated from the hub and remained in the patient.Per the facility the procedure was performed on the patient's lower left abdominal quadrant.According to the facility the needle separated from the hub after the medication was administered.Once the issue was noticed an x-ray was performed to assist in locating the needle.Once located, the surgeon was able to remove the needle and confirm via measurement that the shaft was intact and was completely removed.Per the facility the procedure was completed but the incision site where the needle had to be removed was larger than the two other laparoscopic sites.The sample is not available to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility on (b)(6) 2022 while administering 0.5% bupivacaine with epinephrine intradermally the shaft of a 25 gauge needle separated from the hub and remained in the patient.

• Type of Device: LAPAROSCOPY GYN PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14518015
• MDR Text Key: 292790858
• Report Number: 1423395-2022-00019
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJV0262J
• Device Lot Number: 22AMD379
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2022
• 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): Required Intervention