MEDICHOICE * 1773088101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-16 for MEDICHOICE * 1773088101 manufactured by Owens & Minor, Inc..

Event Text Entries

[932659] Nurse discovered that cord clamp was falling off the umbilical cord. The cord was still in the clamped position. This is the fourth occurrence of this problem. In reviewing these incidents, we have hypothesized that the transponder for the infant security system may have contributed to the failure of the clamp. The transponder is placed in the ring at one end of the clamp. The transponder is held very tightly by clamps from this manufacturer. (nursing staff does not recall having similar problems with our previous clamp manufacturer. ) after reporting these incidents to the clamp manufacturer, we have been informed that their device is not compatible with the transponder system. Also, according to the maker of the transponder system, the only clamp that is designed to be used with the system is their own clamp.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1180283
MDR Report Key1180283
Date Received2008-09-16
Date of Report2008-09-16
Date of Event2008-09-16
Report Date2008-09-16
Date Reported to FDA2008-09-16
Date Added to Maude2008-10-01
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameMEDICHOICE
Generic NameCLAMP, UMBILICAL CORD
Product CodeHFW
Date Received2008-09-16
Model Number*
Catalog Number1773088101
Lot NumberCSG10-01
ID Number*
Device AvailabilityY
Device Age15 HOURS I
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key1209577
ManufacturerOWENS & MINOR, INC.
Manufacturer Address9120 LOCKWOOD BOULEVARD MECHANICSVILLE VA 231162029 US

Device Sequence Number: 2

Brand NameMY CHILD INFANT PROTECTION SYSTEM
Generic NameINFANT ABDUCTION SYSTEM
Product CodeFRP
Date Received2008-09-16
Model NumberUMBILICAL TRANSPONDER PRO-ROAM-UMB
Catalog Number*
Lot Number*
ID Number*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key1209578
ManufacturerPROSEC PROTECTION SYSTEMS INC.
Manufacturer Address1985 SWARTHMORE AVENUE, SUITE LAKEWOOD NJ 08701 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-09-16

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