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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; UNKNOWN STATLOCK DEVICE

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C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE; UNKNOWN STATLOCK DEVICE Back to Search Results
Device Problem Fitting Problem (2183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2023
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
 
Event Description
It was reported that the statlock would not lock/click close over foley.They had replaced in emergency department & office with same issue.Representative explained that bd had 3 types of statlock foleys, one designed for latex foley catheters, one for silicone foley catheters and one universal that should fit both, if they were using a statlock for a material that was not designed then the statlock may not fit.
 
Event Description
It was reported that the statlock would not lock/click close over foley.They had replaced in emergency department & office with same issue.Representative explained that bd had 3 types of statlock foleys, one designed for latex foley catheters, one for silicone foley catheters and one universal that should fit both, if they were using a statlock for a material that was not designed then the statlock may not fit.Per follow up via phone on (b)(6) 2023, it was reported that they had an intermittent catheter in for 10 days, and the several statlocks they used would fall off completely if any tension came to the statlocks.They spoke with urologist to find alternatives and/or substitutes, but they felt the clasp was not the right fit for the catheters they used them with.Also made note that some slight irritation occurred where the statlocks were placed, and they were trying to alleviate the soreness.
 
Manufacturer Narrative
The reported event was inconclusive.A potential root cause for this failure could be due to "inappropriate snap fit ".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog and lot number for this device are unknown.Therefore, bd was unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all 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
UNKNOWN STATLOCK DEVICE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key17585693
MDR Text Key321556437
Report Number1018233-2023-06181
Device Sequence Number1
Product Code EYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/12/2023
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 Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/03/2023
Initial Date FDA Received08/21/2023
Supplement Dates Manufacturer Received10/12/2023
Supplement Dates FDA Received10/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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