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

Catalog Number UNKNOWN

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Material Perforation (2205); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

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, dignishield device used to ensure wound care is not compromised by stool was infused with sodium propagate and it was later noted that the inflation arm appeared to have fallen off or have been cut by the clamp provided in kit.The patient noted that the nurses were "patching holes" on the device as it was leaking.Per troubleshooting, it was noted that the medications which contained petroleum products would be problematic for the device and should not be used on medical devices of this nature additional information on 25 sep 2020, the customer noted that the dignishield was leaking from the tube so the tube was clamped but the clamp then cut the tube.The tube was replaced and clamped but the leak persisted.After the clamp was removed, there was a cut on the tube where the clamp was placed.

Manufacturer Narrative

The reported event was confirmed, however the cause was unknown.Visual evaluation of the returned sample noted one opened (without original packaging), used dignishield were used.It was noted that the tubing had jagged, uneven cuts closer to the cuff end, but past the transphincteric zone.The clamp could not be examined for its relation to the failure as it was not returned.The device specification could not be found as the product identity was unknown.The product had caused the reported failure.A potential root cause for this failure could be due to ¿clip used for medical delivery." the product used for treatment purposes.The specifications for this exact failure could not be found due to the product being unknown, however the reported failure was considered out of the specifications because the reported failure was observed.The lot number was unknown, therefore, the device history record could not be reviewed.The product catalog 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 actual/suspected device was inspected.

Event Description

It was reported that the dignishield device used to ensure wound care was not compromised by stool.Infused with sodium propagate, and it was later noted that the inflation arm appeared to have fallen off or have been cut by the clamp provided in the kit.The patient noted that the nurse were patching holes on the device as it was leaking.Per troubleshooting, it was noted that the medications which contained petroleum products  would be problematic for the device and should not be used in medical devices of this nature.Per additional information received on 25sep2020, the customer noted that the dignishield was leaking from the tube, so the tube was clamped, but the clamp cuts the tube.The tube was replaced and clamped, but the leak persisted.  after the clamp was removed, there was a cut on the tube where the clamp was placed.

• 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: 10828648
• MDR Text Key: 217439928
• Report Number: 1018233-2020-20908
• 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: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other