R-PEAN FCPS 6-1/4 CVD MIRROR 105171

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-03 for R-PEAN FCPS 6-1/4 CVD MIRROR 105171 manufactured by Integra York, Pa Inc..

Event Text Entries

[3874677] (b)(4). Kelly clamp was handed to doctor by certified surgical technologist (cst) at delivery to clamp the umbilical cord to obtain a segment of cord blood. The head of the clamp broke away from the body of the clamp when she attempted to lock the handle.
Patient Sequence No: 1, Text Type: D, B5

[11191412] To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2523190-2013-00056
• MDR Report Key: 3381897
• Report Source: 06
• Date Received: 2013-09-03
• Date of Report: 2013-09-03
• Date of Event: 2013-06-30
• Date Mfgr Received: 2013-08-13
• Date Added to Maude: 2013-10-07
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: SANDRA LEE
• Manufacturer Street: 315 ENTERPRISE DRIVE
• Manufacturer Phone: 6099366828
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: R-PEAN FCPS 6-1/4 CVD MIRROR
• Generic Name: NA
• Product Code: NMF
• Date Received: 2013-09-03
• Catalog Number: 105171
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA YORK, PA INC.
• Manufacturer Address: YORK PA 17402 US 17402

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-09-03