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

Model Number FOL0102

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the hitch of the clamp was separating from the adhesive when removing from leg.Per sample received on 08may2023, the customer returned two used devices.Per additional information received via sample form on 08may2023, customer stated that this type unit had failed several times causing the catheter to separate itself from the bag at the attach point.Device was replaced.Customer stated that upon inspection of each failed device they all have failed for the same reason, it did not appear that the glue type or application procedure was working out in attaching the statlock swivel unit to the cloth adhesive base.Customer shower each morning with unit attached, using soap and water on the bag and exposed portion of the catheter.

Manufacturer Narrative

The reported event is confirmed and the cause was unknown.The potential root cause could be incorrect conveyor setup.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not required because labeling could not have prevented the reported failure.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 hitch of the clamp was separating from the adhesive when removing from leg.Per sample received on 08may2023, the customer returned two used devices.Per additional information received via sample form on 08may2023, customer stated that this type unit had failed several times causing the catheter to separate itself from the bag at the attach point.Device was replaced.Customer stated that upon inspection of each failed device they all have failed for the same reason, it did not appear that the glue type or application procedure was working out in attaching the statlock swivel unit to the cloth adhesive base.Customer shower each morning with unit attached, using soap and water on the bag and exposed portion of the catheter.

• 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 Key: 16938860
• MDR Text Key: 315296196
• Report Number: 1018233-2023-03462
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FOL0102
• Device Catalogue Number: FOL0102
• Device Lot Number: JUHN8739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 102 KG