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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 Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2023
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 patient had a statlock in situ and the plastic clamp had come apart from the adhesive dressing.The clamp was still in situ on the catheter but was not secured.Both parts were removed and saved to be sent off for analysis.The statlock was used when the catheter was inserted using the bard lubrisil tray and the catheter was inserted on (b)(6)2023.The catheter was longer secured in statlock but as far as they were aware, there was no direct impact.Per follow-up information received from ibc on (b)(6)2023, stated that there was no defect with the catheter as far as they were aware.The defect was with the statlock as reported.
 
Event Description
It was reported that the patient had a statlock in situ and the plastic clamp had come apart from the adhesive dressing.The clamp was still in situ on the catheter but was not secured.Both parts were removed and saved to be sent off for analysis.The statlock was used when the catheter was inserted using the bard lubrisil tray and the catheter was inserted on (b)(6) 2023.The catheter was longer secured in statlock but as far as they were aware, there was no direct impact.Per follow-up information received from ibc on 02mar2023, stated that there was no defect with the catheter as far as they were aware.The defect was with the statlock as reported.
 
Manufacturer Narrative
The reported event was confirmed and the cause was unknown.Although an exact root cause could not be determined a potential root cause could be incorrect dimensions between mating parts.The lot number was unknown; therefore, the device history record could not be reviewed.Labelling review was not required as it would not have prevented the reported event.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.
 
Manufacturer Narrative
The reported event was confirmed and the cause was unknown.Although an exact root cause could not be determined a potential root cause could be incorrect dimensions between mating parts.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "prep 1.Place foley catheter into retainer.Directional arrow should point towards catheter tip, and balloon inflation arm should be next to the clamp hinge.2.Close lid, being careful to avoid pinching the catheter.3.Identify securement site by laying the device retainer on the front of the thigh, leaving.1 inch of catheter slack between insertion site and the statlock® device retainer.4.After placing the statlock® stabilization device off to the side, cleanse and degrease the securement site with alcohol per hospital policy.Let skin dry.5.Apply skin protectant, in direction of hair growth, to area larger than securement site.Allow to dry completely (10-15 seconds).6.Using permanent marker, write initials and date of application on the statlock® device anchor pad.Note: always secure catheter into the statlock® device retainer before applying adhesive pad on skin.Place and peel 7.Align the statlock® stabilization device over securement site leaving 1 inch of catheter slack.Make sure leg is fully extended.8.While holding the retainer to keep the pad in place, peel away paper backing, one side at a time and place tension-free on skin.Removal technique: disengage 1.Open retainer by pressing release button with thumb, then lift to open.2.Remove foley catheter from the statlock® device.Dissolve 3.Wipe the edge of the pad using at least 5-6 alcohol pads until a corner lifts.Then continue to stroke undersurface of pad with alcohol to dissolve adhesive pad away from skin.Do not pull or force pad to remove." h11: section a through f - the information provided by bard 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 bard.H3 other text: the actual/suspected device was inspected.
 
Event Description
It was reported that the patient had a statlock in situ and the plastic clamp had come apart from the adhesive dressing.The clamp was still in situ on the catheter but was not secured.Both parts were removed and saved to be sent off for analysis.The statlock was used when the catheter was inserted using the bard lubrisil tray and the catheter was inserted on (b)(6) 2023.The catheter was longer secured in statlock but as far as they were aware, there was no direct impact.Per follow-up information received from ibc on 02mar2023, stated that there was no defect with the catheter as far as they were aware.The defect was with the statlock as reported.
 
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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
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key16536668
MDR Text Key311219432
Report Number1018233-2023-01707
Device Sequence Number1
Product Code EYJ
UDI-Device Identifier00801741076114
UDI-Public(01)00801741076114
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFOL0102
Device Catalogue NumberFOL0102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2023
Was Device Evaluated by Manufacturer? Yes
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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