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

Catalog Number F271.06

Device Problems Break (1069); Entrapment of Device (1212); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 18dec2018 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

Sales rep reported via email: tip of aspiration needle broke off in patient.Surgeon had to retrieve the tip.On 20dec2018: additional information: what i¿ve been told is the tip was bent and had to be broken off in the patient, so the needle could be removed; of course the surgeon had the tip as well as they never lost sight of it.Procedure went as planned and was successful.All parts were returned but i didn¿t record the lot number.What was the procedure that was being performed? laparoscopic cholecystectomy.Did any part the instrument fall into the patient¿s body, and if so, how was it retrieved? from my understanding, the tip of the instrument was inserted into the gallbladder and upon insertion the tip broke off or partially broke off.I¿m not sure if the instrument was able to be removed with the tip partially on or if they used a grasper to retrieve the tip.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no.The entire instrument was accounted for, so no x-ray was performed.What was the patient¿s outcome? the patient outcome was normal for the procedure performed.Was the procedure completed as planned? the procedure was completed as planned.Can you please send all parts of the instrument for evaluation? yes, all parts can be sent for evaluation.Do you have the lot number? i do not have the lot number; no further information available.

Manufacturer Narrative

Follow up (b)(6) the sample was provided, and an evaluation was performed.The root cause of the reported issue is due to improper use.The supplier received one needle with a broken tip and noted that the needle looks misused and abused.Needle tip is blunt and damaged.It appears as though needle was already damaged prior to being used in procedure.A needle will not bend, become blunt, or appear the way it was received, after one use.Needles must be evaluated before use.If they appear blunt or bent, they need to be replaced or resharpened.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.The reported issue will continue to be trended and evaluated by bd.

Event Description

Sales rep reported via email: tip of aspiration needle broke off in patient.Surgeon had to retrieve the tip.On 20dec2018 additional information: what i¿ve been told is the tip was bent and had to be broken off in the patient, so the needle could be removed, of course the surgeon had the tip as well as they never lost sight of it.Procedure went as planned and was successful.All parts were returned but i didn¿t record the lot number.1.What was the procedure that was being performed? laparoscopic cholecystectomy 2.Did any part the instrument fall into the patient¿s body, and if so, how was it retrieved? from my understanding, the tip of the instrument was inserted into the gallbladder and upon insertion the tip broke off or partially broke off.I¿m not sure if the instrument was able to be removed with the tip partially on or if they used a grasper to retrieve the tip.3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no.The entire instrument was accounted for, so no x-ray was performed.4.What was the patient¿s outcome? the patient outcome was normal for the procedure performed.5.Was the procedure completed as planned? the procedure was completed as planned 6.Can you please send all parts of the instrument for evaluation? yes, all parts can be sent for evaluation.7.Do you have the lot number? i do not have the lot number no further information available.

• Brand Name: INJECTION NEEDLE 18GA 32CM LONG
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 8189122
• MDR Text Key: 131499358
• Report Number: 1423507-2018-00025
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: F271.06
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other