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

Model Number FOL0102

Device Problem Sharp Edges (4013)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

It was reported that inside of the foley statlocks appeared to have sharp teeth that were damaging the catheter integrity and customer noticed tiny holes in the catheter.The user monitored it to see if it would spike right through the silicone catheter.It was stated that customer had been trimming the teeth like structures off.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event is inconclusive as the evaluated sample meets specifications and the condition of the original used sample is unknown.Visual evaluation noted received 1 statlock stabilization device with original open packaging.Placed in house foley catheter within statlock stabilization device.Foley catheter remained in tact no holes occurred onto catheter.Therefore, product meets specifications.Although an exact root cause could not be determined a potential root cause could be clamp spikes too long.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required because labeling could not have prevented the reported issue.The actual/suspected device was evaluated.

Event Description

It was reported that inside of the foley statlocks appeared to have sharp teeth that were damaging the catheter integrity and customer noticed tiny holes in the catheter.The user monitored it to see if it would spike right through the silicone catheter.It was stated that customer had been trimming the teeth like structures off.

• Brand Name: CATHETER STABILIZATION DEVICE
• Type of Device: STATLOCK
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15258310
• MDR Text Key: 305060788
• Report Number: 1018233-2022-06564
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FOL0102
• Device Catalogue Number: FOL0102
• Device Lot Number: JUFZ2077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2022
• 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