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

Catalog Number FOL0102

Device Problem Disconnection (1171)

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

It was reported that the plastic part of the statlock got detached and the catheter was unable to fix.

Manufacturer Narrative

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

Manufacturer Narrative

The investigation is confirmed-cause unknown.Visual inspection noted 1 statlock foley stabilization device was received with no packaging.Inspection noted that clamp door easily falls off swivel base.The product failed to meet specifications.Although an exact root cause could not be determined, a potential root cause could be incorrect dimensions between mating parts.The product was used for patient diagnostic or treatment.It was unknown whether the product had caused the reported failure.A dhr review did not show any problems or conditions that would have contributed to the reported event.Based on the results of this investigation no additional actions are required at this time.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labelling review is not required as it would not have prevented the reported failure.The actual/suspected device was inspected.

Event Description

It was reported that the plastic part of the statlock got detached and the catheter was unable to fix.Per follow up via ibc on 09mar2022, catheter came off referred to that the statlock (foley stabilization device) could not stabilize the catheter, since the retainer came off.

• 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 Key: 13921206
• MDR Text Key: 288055462
• Report Number: 1018233-2022-01629
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: FOL0102
• Device Lot Number: JUFW0511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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