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

Catalog Number UNKNOWN

Device Problem Material Too Soft/Flexible (4007)

Patient Problems Ulceration (2116); Ulcer (2274)

Event Date 09/15/2020

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 the fms system had too flexible were the cuff allows it to kink and leak and tubing got twisted on itself.The patient had a number of anal ulcerations with the use of the dignishield.No medical intervention was reported.Per additional information, the dignishield has a low pressure cuff therefore it is unnecessary to periodically inflate and deflate the cuff.If they need to deflate the balloon to check the volume this will be a facility decision.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met relevant specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be due to materials of construction are not biocompatible.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The product catalog number and lot number for this device was unknown.Therefore bd was unable to determine the associated labeling to review.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.H3 other text : the device was not returned.

Event Description

It was reported that the fecal management system was too flexible the cuff allows it to kink and leak and the tubing gets twisted on itself.The patient had a number of anal ulcerations with the use of the dignishield.No medical intervention was reported.Per additional information the dignishield had a low pressure cuff therefore it was unnecessary to periodically inflate and deflate the cuff.If they need to deflate the balloon to check the volume this will be a facility decision.Per follow up 2 via email on 05oct2020 the wound care applied a skin protectant to protect the area from further ulceration.

• Brand Name: UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
• Type of Device: DIGNISHIELD
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10687206
• MDR Text Key: 213480238
• Report Number: 1018233-2020-20152
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other