MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. BARIATRIC PACK REORDER; LAPAROSCOPY KIT

Model Number DYNJ905153K

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

Metal part of the injection needle that comes with the bariatric pack broke off while injecting local anesthesia.Ultrasound and c-arm imaging was used to localize the needle.The needle was between the patient's skin and peritoneum.Dr was able to get the needle out by pushing the needle into the peritoneum with direct visualization from the laparoscope and grabbed it with a maryland grasper.Bariatric pack reorder no: (b)(4), lot: 22imf393, gtin (b)(4), exp: 10/31/2023.

• Brand Name: BARIATRIC PACK REORDER
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 16026542
• MDR Text Key: 306076520
• Report Number: MW5113909
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10195327187866
• UDI-Public: (01)10195327187866
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/31/2023
• Device Model Number: DYNJ905153K
• Device Catalogue Number: DYNJ905153K
• Device Lot Number: 22IMF393
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White