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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CATHETER STABILIZATION DEVICE

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C.R. BARD, INC. (COVINGTON) -1018233 CATHETER STABILIZATION DEVICE Back to Search Results
Catalog Number FOL0102
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/04/2023
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 white clip on statlock was coming apart and falling off.Stated that the statlock was beginning to peel off quite easily.Per follow-up information received from ibc on 24jul2023, stated that the defect was found after use on the patient.
 
Event Description
It was reported that the white clip on statlock was coming apart and falling off.Stated that the statlock was beginning to peel off quite easily.Per follow-up information received from ibc on 24jul2023, stated that the defect was found after use on the patient.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "adhesive chemistry not appropriate for application (poor quick stick characteristics)".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "application technique prep: 1.Place foley catheter into retainer.Directional arrow should point towards catheter tip, and balloon inflation arm should be next to the 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 2.5 cm 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 2.5 cm 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." 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.
 
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Brand Name
CATHETER STABILIZATION DEVICE
Type of Device
CATHETER STABILIZATION 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 Key17389846
MDR Text Key319695965
Report Number1018233-2023-05450
Device Sequence Number1
Product Code EYJ
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,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/26/2023
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
Device Catalogue NumberFOL0102
Device Lot NumberJUGT1504
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/04/2023
Initial Date FDA Received07/25/2023
Supplement Dates Manufacturer Received07/26/2023
Supplement Dates FDA Received07/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2022
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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