MAUDE Adverse Event Report: CAREFUSION UNK V. MUELLER; RETRACTOR, FIBEROPTIC

Model Number UNK V. MUELLER

Device Problems Component Falling (1105); Material Frayed (1262)

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

Event Date 03/06/2014

Event Type  malfunction  

Event Description

Damaged product medwatch (b)(4).Additional information received from the customer (b)(4) 2014.The customer stated that our tebbetts retractors were attached to the light source when the light source frayed and fell into the patient's open breast.He did not believe there was any patient harm.He stated he had no further information at this time.He stated that the instruments would not be sent for evaluation but did offer to allow us to come to the facility to evaluated during a customer visit.

Manufacturer Narrative

(b)(4).Should additional information be received, a follow-up emdr will be submitted.

Manufacturer Narrative

(b)(4) further information was obtained by the sales rep during his visit to the facility on (b)(6) 2014.The sales rep reported that there were four (4) tebbetts retractors used in the case, which is two (2) more then originally reported by the customer.The lot numbers and product numbers were unknown.The hospital could not identify which of the four tebbetts retractor was used in the case.No photos were taken of the tebbetts retractors.The bio med manager tested all four of the retractors and did not find any issues.The sales rep was able to take pictures of the light cable (product code (b)(4),lot number 833502) listed in case (b)(4) whos investigation concluded created the failure.

• Brand Name: UNK V. MUELLER
• Type of Device: RETRACTOR, FIBEROPTIC
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC. SNOWDEN PENCER PRODUCTS; 5175 south royal atlanta dr; tucker 30084
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3701317
• MDR Text Key: 18361610
• Report Number: 1038548-2014-00036
• Device Sequence Number: 1
• Product Code: FDG
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 61