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

Catalog Number UNKNOWN

Device Problems Loss of or Failure to Bond (1068); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 fitting between the bard catheter and the bag kept coming apart and was not secured back together.The holders that stuck to the skin only lasted for a short time.As a result, the patient needed help to put a new bag on and to make the bag secured on the leg.The customer was currently using 18fr catheter and enquired about a longer catheter or other method to secure the bag.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to ¿pad material incompatible with adhesive (poor surface treatment)".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the statlock foley product ifus were found to be adequate based on past reviews.

Event Description

It was reported that the fitting between the bard catheter and the bag kept coming apart and was not secured back together.The holders that stuck to the skin only lasted for a short time.As a result, the patient needed help to put a new bag on and to make the bag secured on the leg.The customer was currently using 18fr catheter and enquired about a longer catheter or other method to secure the bag.

• Brand Name: UNKNOWN STATLOCK DEVICE
• Type of Device: UNKNOWN STATLOCK DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10407314
• MDR Text Key: 203667230
• Report Number: 1018233-2020-05187
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1