MAUDE Adverse Event Report: CAREFUSION, INC HALSTED MICRO ARTERY FORCEPS CVD 5IN; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number SU2699

Device Problems Appropriate Term/Code Not Available (3191); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018 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: doctor had an incident happen in the operating room, while using an instrument (su2699) out of his basic nuero set.It cut the suture and the needle fell into the patient.It was recovered but we are wondering why this is happening and if anything like this has ever been reported by anyone else to the company.We are going to take out and test all the instruments in all of his sets and see if they all cut through suture.No further information available.

Manufacturer Narrative

(b)(4).Follow up - the product was not returned for evaluation and the lot code is unknown.The customer communicated that ¿it was determined that it was not the product that caused an issue.It has been resolved and there was no patient impact¿.No further information is available.H3 other text : see h10.

Event Description

Sales rep reported via email: doctor had an incident happen in the or, while using an instrument (su2699) out of his basic nuero set.It cut the suture and the needle fell into the patient.It was recovered but we are wondering why this is happening and if anything like this has ever been reported by anyone else to the company.We are going to take out and test all the instruments in all of his sets and see if they all cut through suture.No further information available.

• Brand Name: HALSTED MICRO ARTERY FORCEPS CVD 5IN
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 8812378
• MDR Text Key: 151858694
• Report Number: 1423507-2019-00012
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SU2699
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other