SAFETY DRAIN 132

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-09-15 for SAFETY DRAIN 132 manufactured by Kimberly-clark/ballard.

Event Text Entries

[658543] An incident report was received through the kimberly-clark sales rep on behalf of the user facility. The safety drain devices had leaks at the suction port and caused pressure loss. One pt went into bradycardia with peep (positive end expiratory pressure) of 18 and fio2 at 80 percent. The user facility stated that there was no medical intervention. Kimberly-clark or ballard has no first hand knowledge of the allegations but is relaying info received from outside sources pursuant to federal regulations.
Patient Sequence No: 1, Text Type: D, B5


[7807426] The mfr of this product line is in the process of being relocated, along with the associated testing equipment. Until the equipment is validated and the returned devices can be thoroughly tested, no conclusion can be drawn at this time. A supplemental report will be filed with the test results when the evaluations have been completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3031042-2006-00045
MDR Report Key876338
Report Source06,07
Date Received2006-09-15
Date of Report2006-09-15
Date of Event2006-08-18
Date Mfgr Received2006-08-18
Date Added to Maude2007-07-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactSALLY HERRICK
Manufacturer Street1400 HOLCOMB BRIDGE RD
Manufacturer CityROSWELL GA 30076
Manufacturer CountryUS
Manufacturer Postal30076
Manufacturer Phone7705877244
Manufacturer G1*
Manufacturer Street1999 ALVIN RICKEN DR
Manufacturer CityPOCATELLO ID 83201
Manufacturer CountryUS
Manufacturer Postal Code83201
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSAFETY DRAIN
Generic NameDRAIN, TEE (WATER TRAP)
Product CodeBYH
Date Received2006-09-15
Returned To Mfg2006-09-08
Model NumberNA
Catalog Number132
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key855835
ManufacturerKIMBERLY-CLARK/BALLARD
Manufacturer Address* POCATELLO ID * US


Patients

Patient NumberTreatmentOutcomeDate
10 2006-09-15

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