MAUDE Adverse Event Report: CAREFUSION, INC USA RETRACTOR DBL-END 8IN 2/ST

Model Number SU3660

Device Problems Crack (1135); Fail-Safe Problem (2936); Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(4) initial emdr.A device is anticipated for investigation.Once the investigation has been completed a supplemental emdr will be submitted for the investigation results.If any additional information is received a supplemental will be submitted with those details.

Event Description

It was reported that there was a burn on patient's skin when insulated army navy retractor was moved.Operator noticed cracks in the insulation.

Event Description

It was reported that there was a burn on patient's skin when insulated army navy retractor was moved.Operator noticed cracks in the insulation.

Manufacturer Narrative

(b)(4) supplemental emdr there was no sample or photo available to bd for evaluation after multiple attempts to retrieve it.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record could not be performed as the lot number was unknown.H3 other text : no sample or lot available for evaluation.

• Brand Name: USA RETRACTOR DBL-END 8IN 2/ST
• Type of Device: RETRACTOR
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer (Section G): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13694758
• MDR Text Key: 289332463
• Report Number: 1423507-2022-00005
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10885403132803
• UDI-Public: (01)10885403132803
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SU3660
• Device Catalogue Number: SU3660
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• 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