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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE
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C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE Back to Search Results
Device Problem Sharp Edges (4013)
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.The device was not returned.
 
Event Description
It was reported that statlock was puncturing the foley catheter due to a sharp edge.As per follow up, due to the location of where the tube was perforated, the patient required a replacement of the device.The device was in use for few hours and the issue was noticed while performing the assessment following postop admission.
 
Event Description
It was reported that statlock was puncturing the foley catheter due to a sharp edge.As per follow up, due to the location of where the tube was perforated, the patient required a replacement of the device.The device was in use for few hours and the issue was noticed while performing the assessment following postop admission.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "clamp spikes too long".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
 
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Brand Name
STATLOCK SL FOLEY, UNKNOWN CODE
Type of Device
STATLOCK
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10323608
MDR Text Key201357702
Report Number1018233-2020-04782
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 other,user facility
Type of Report Initial,Followup
Report Date 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/02/2020
Initial Date FDA Received07/24/2020
Supplement Dates Manufacturer Received09/17/2020
Supplement Dates FDA Received10/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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