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

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that four of the statlock foley stabilization devices that were peeling off.As per follow-up via phone on 16nov2022, it was reported that the adhesive on the statlock was not sticking as it should and was just peeling off.

Event Description

It was reported that four of the statlock foley stabilization devices that were peeling off.Per follow-up via phone on (b)(6)2022, it was reported that the adhesive on the statlock was not sticking as it should and was just peeling off.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be ¿adhesive chemistry not appropriate for application (poor quick stick characteristics)".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.H11: 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.H3 other text : the device was not returned.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: STATLOCK SL FOLEY
• 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: 15878516
• MDR Text Key: 304888067
• Report Number: 1018233-2022-09041
• Device Sequence Number: 1
• Product Code: EYJ
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• 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