MAUDE Adverse Event Report: CAREFUSION, INC INJECTION NEEDLE 18GA 32CM LONG; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number F271.06

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

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

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) on 03jul2018 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

Tip broke off in case yesterday when used on a gallbladder.Lot number l17eei.On 09jul2018 additional information: what was the procedure that was being performed? lap chole.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes, the needle tip broke off and was removed with long grasper.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no they visually saw and removed it.What was the patient¿s outcome? successful.Was the procedure completed as planned? yes.Can you please send all parts of the instrument for evaluation? gave to sales rep.

Manufacturer Narrative

Follow up mdr 474910.The sample was provided, and an evaluation was performed.The root cause of the reported issue is due to improper use of the device.The bend of the needle is clear evidence that the injection needle was not used as intended.A microscopic examination of the needle weld also did not show any signs of an incomplete weld.A detailed inspection revealed that the current manufacturing process was followed and that this incident does not warrant any changes to be implemented.A visual test showed no signs of spotting by the luer lock.The needle was bent at the distal end.The bent needle suggests that the instrument was dropped before or it was bent during surgery possibly by hitting something other than soft tissue.That impact caused the distal end of the needle to bend and become damaged.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: INJECTION NEEDLE 18GA 32CM LONG
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 7715487
• MDR Text Key: 115283106
• Report Number: 1423507-2018-00012
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K060233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: F271.06
• Device Lot Number: L17EEI
• Date Manufacturer Received: 07/03/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other