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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN STATLOCK DEVICE
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN STATLOCK DEVICE Back to Search Results
Catalog Number UNKNOWN
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the plastic swivel clip had broken off within a day or two after use.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "inadequate material strength".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the statlock foley product ifus were found to be adequate based on past reviews.
 
Event Description
It was reported that the plastic swivel clip had broken off within a day or two after use.
 
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Brand Name
UNKNOWN STATLOCK DEVICE
Type of Device
STATLOCK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10404503
MDR Text Key203641903
Report Number1018233-2020-05165
Device Sequence Number1
Product Code EYJ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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