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

Model Number	DYNJ905153K
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 16026542
• Report Number: MW5113909
• Device Sequence Number: 5462961
• Product Code: FDE
• UDI-Device Identifier: 10195327187866
• UDI-Public: (01)10195327187866
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White