MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM

Model Number SMS002

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

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 metal spring in the dignishield sprung loose.

Manufacturer Narrative

The reported event was confirmed.The device did not met specifications.The product was used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the returned sample noted one opened (inside original packaging), dignishield stool management system.Visual inspection of the sample noted that the cuff was missing from the device, appearing to have been cut off at the point where the cuff meets the tube.This was done by the complainant before return of the sample.Additionally, the nickel alloy spring was detached from the piston valve attachment.This is out of specification per inspection procedure, which states "no missing components are allowed.All parts shall be present and located according to drawing." clearly illustrates the spring in the correct position in the piston valve subassembly.The spring was found loose in the packaging.The green lever moved with no resistance as a result of the detached spring.The bag was not able to be engaged or disengaged from the catheter device as a consequence.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿damaged components.¿ the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿the bard® dignishield® stool management system (sms) with odor barrier properties is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients and to provide access for the administration of medications.Adult use only.Device description: the bard® dignishield® sms device consists of a catheter tube assembly, a collection bag (figure 1), a 60 ml syringe, a syringe of lubricating jelly and a biological odor eliminator.The device has no components made of natural rubber latex.Figure 1 ¿ catheter tube assembly and collection bag position indicator line contents: ¿ catheter tube assembly (figure 1 includes collection bag) ¿ collection bag ¿ 60 ml syringe ¿ lubricating jelly syringe (10 ml) ¿ instructions for use ¿ 1 bottle (1 oz) of medi-aire® biological odor eliminator ¿ tube clamp the bard® dignishield® sms catheter tube assembly consists of a catheter body and collection bag assembly that is primarily constructed of a proprietary copolymer material called permalene¿, bonded to a low-pressure retention cuff and trans-sphincteric zone (tsz) primarily constructed of silicone material." 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 metal spring in the dignishield sprung loose.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
• Type of Device: DIGNISHIELD
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9072527
• MDR Text Key: 188866694
• Report Number: 1018233-2019-05676
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741045943
• UDI-Public: (01)00801741045943
• Combination Product (y/n): N
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: SMS002
• Device Catalogue Number: SMS002
• Device Lot Number: NGDN1072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1