MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE; UNKNOWN STATLOCK DEVICE

Model Number FOL0100

Device Problem Disconnection (1171)

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

Event Date 08/23/2022

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 there were 2 incidents on april and may where the foley statlock did not stay clipped around the catheter tubing and stated that the nurse changed the statlock approximately every 4 weeks.Per investigator notification on (b)(6) 2022, stated that the customer returned 3 additional stabilization devices that were used.

Manufacturer Narrative

The reported event is unconfirmed as the original sample received meets specifications.Visual evaluation noted received 1 statlock stabilization device with no original packaging.In house foley catheter was placed onto clamp.Clamp securely held catheter in place.However, clamp was disconnected.Unable to do a dhr review as the lot number is unknown.Based on the results of this investigation no additional actions are required at this time.Risk review and labelling review are not required as the reported event is unconfirmed the actual/suspected device was inspected.

Event Description

It was reported that there were 2 incidents on april and may where the foley statlock did not stay clipped around the catheter tubing and stated that the nurse changed the statlock approximately every 4 weeks.Per investigator notification on 23aug2022, stated that the customer returned 3 additional stabilization devices that were used per notification from investigator on 09sep2022, it was found that the clamp was disconnected from the swivel base during sample evaluation.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: UNKNOWN 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15328083
• MDR Text Key: 305146657
• Report Number: 1018233-2022-06809
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076077
• UDI-Public: (01)00801741076077
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FOL0100
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• 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 Number: 1
• Patient Outcome(s): Other