MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FECAL MANAGEMENT (DIGNISHIELD); FECAL MANAGEMENT SYSTEM

Catalog Number UNKNOWN

Device Problems Crack (1135); Inflation Problem (1310); Leak/Splash (1354)

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 fecal management system (fms) was leaking more now, the tubing was cracked, and the balloon did not always inflate.

Manufacturer Narrative

The reported event was inconclusive due to poor sample condition.No sample was returned for evaluation.Visual inspection noted two photo samples were received.Visual evaluation noted that both of the photos show a portion of the tubing that has cracking throughout with the device leaking out.The photos do not show the balloon of the device, and therefore it is unknown if the device was able to inflate.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be punctured lumen.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 fecal management system ifus were found to be adequate based on past reviews.H11:section a through f - the information provided by bd represents all of 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.

Event Description

It was reported that the fecal management system (fms) was leaking more now, the tubing was cracked, and the balloon did not always inflate.

• Brand Name: UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
• Type of Device: FECAL MANAGEMENT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10398121
• MDR Text Key: 203461209
• Report Number: 1018233-2020-05122
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/15/2020

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1