MAUDE Adverse Event Report: CAREFUSION UNKNOWN V. MUELLER DEVICE; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number UNK - V. MUELLER

Device Problem Break (1069)

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

Event Date 10/16/2014

Event Type  malfunction  

Event Description

User facility medwatch #mw5038854 report stated " pean broke near the joint of the handle while clamping the umbilical cord.No injury to the patient but resulted in a cut to the physicians glove.Hand examined and no cut noted.Dates of use (b)(6) 2014" additional information received 07apr2015: the customer reported when the physician placed pean clamp on the cord on the placenta, pean broke at the bottom of the handle.The c-section procedure was completed as planned.The physician's glove was cut, contaminated glove removed.Further examination of hand no injury noted.The physician required no medical interventions, washed hand not injury, replace sterile gloves.No patient impact, x-rays obtained per protocol.Radiology review of x-ray and viewed by surgeon, no fragments noted.The reported product was a v.Mueller clamp, pean, artery, straight 6 1/2".Additional information received 08apr2015: the customer reported the x-ray was performed due to the broken instrument, to check for and rule out retained fragments.

Manufacturer Narrative

(b)(4): if further information becomes available a follow up medwatch will be submitted.

Manufacturer Narrative

(b)(4): the complaint instrument was provided and an evaluation was performed by carefusion cuatomer advocacy.The instrument has no identified lot number and is likely over 25 years old.There is no complete product number or lot number etched on the instrument.There is however indication that this is a v.Mueller product.The ¿v.Mueller¿ stamp can be slightly identified.There is an alpha identification code pl stamped after the ¿v.Mueller¿ logo also.The origin of the ¿pl¿ marking was undetermined.The rfid origin on the device was also unknown.A supplier query was forwarded to the probable manufacturers along with the device and pictures.Manufacturing for this product could not confirm that the instrument was produced by either facility.The supplier and origin of manufacturing was undetermined.The investigation determined the cause of the break during procedure was most likely a crack already present near the proximal joint from the handle of the device before use.The crack appears to have been reprocessed several times noted by the buildup of oxidized material at the broken and exposed area of the arm.

• Brand Name: UNKNOWN V. MUELLER DEVICE
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200 INC (ST. LOUIS); 5 sunnen dr; st. louis 63143
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4697105
• MDR Text Key: 5643172
• Report Number: 1923569-2015-00017
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

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 Operator: Physician
• Device Model Number: UNK - V. MUELLER
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1