MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 FOLEY STATLOCK ADLT FOR LTX AND SIL CATH; STATLOCK DEVICE

Model Number FOL0102

Device Problem Disconnection (1171)

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

Event Date 08/03/2021

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 the statlock locking mechanisms on the product continued to break off.Customer was not sure if it was from lot jufs0395 or jufq0588 but stated they were almost positive that it was from lot jufs0395.Per follow up via email on (b)(6) 2021, the entire plastic locking mechanisms came completely off the pads.The pad stayed glued to their leg.Unfortunately, they threw them away after the pad off from the patient leg because they were so sticky.The patient suffered no ill effect from the breakage.The first one lasted 2 days and the second one lasted about 2 1/2 days.Patient also stated that they had several comorbidities.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.

Event Description

It was reported that the statlock locking mechanisms on the product continued to break off.Customer was not sure if it was from lot jufs0395 or jufq0588 but stated they were almost positive that it was from lot jufs0395.Per follow up via email on 03aug21, the entire plastic locking mechanisms came completely off the pads.The pad stayed glued to their leg.Unfortunately, they threw them away after the pad off from the patient leg because they were so sticky.The patient suffered no ill effect from the breakage.The first one lasted 2 days and the second one lasted about 2 1/2 days.Patient also stated that they had several comorbidities.

• Brand Name: FOLEY STATLOCK ADLT FOR LTX AND SIL CATH
• 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: 12391475
• MDR Text Key: 268915458
• Report Number: 1018233-2021-05299
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

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 Model Number: FOL0102
• Device Catalogue Number: FOL0102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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