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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK DEVICE

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C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK DEVICE Back to Search Results
Model Number FOL0102
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
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 customer wanted to know why only one little swab was there when there used to be two swabs in the tray.The customer also stated that they were having issues with the statlock not sticking.It was also stated that this was an ongoing issue for at the least the last 6 months.The customer also mentioned that they received product through the veterans administration.Per customer contact via phone on 13aug2021, it was stated that, now, statlocks are only coming with one skin prep pack and also the statlocks were not sticking well.It was stated that sometimes, the statlock did not stick on a full day.This had been ongoing for about six months.It was also stated that skin prep wipes were sometimes dried out.
 
Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.
 
Event Description
It was reported that the customer wanted to know why only one little swab was there when there used to be two swabs in the tray.The customer also stated that they were having issues with the statlock not sticking.It was also stated that this was an ongoing issue for at the least the last 6 months.The customer also mentioned that they received product through the veterans administration.Per customer contact via phone on 13aug2021, it was stated that, now, statlocks are only coming with one skin prep pack and also the statlocks were not sticking well.It was stated that sometimes, the statlock did not stick on a full day.This had been ongoing for about six months.It was also stated that skin prep wipes were sometimes dried out.
 
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Brand Name
SL FOLEY SWIVEL SILICONE TRICOT 25BX
Type of Device
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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key12427043
MDR Text Key270485890
Report Number1018233-2021-05439
Device Sequence Number1
Product Code EYJ
UDI-Device Identifier00801741076114
UDI-Public(01)00801741076114
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,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/02/2021
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
Device Model NumberFOL0102
Device Catalogue NumberFOL0102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/13/2021
Initial Date FDA Received09/06/2021
Supplement Dates Manufacturer Received10/29/2021
Supplement Dates FDA Received11/22/2021
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;
Patient SexMale
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