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

Model Number	SMS2B1L
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the quantity of dignishield collection bag measure was not accurate.For example, liquid within the bag will read 150 ml when held level, but when emptied it measures 100 ml.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was inconclusive since the physical sample was not returned for evaluation.It is unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.Visual evaluation of the attached photo sample noted 4 photos of dignishield collection bags filled with different mls of solution, and 1 photo of a measuring device filled with 1000cc of solution.The volume accuracy presented in the photos cannot be confirmed without the physical sample returned.The sample cannot be tested to confirm the volume accuracy.A potential root cause could be markings printed incorrectly.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.Corrections: d, g, h.H11: section a through f - the information provided by bd represents all 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 or Problem Description
It was reported that the quantity of dignishield collection bag measure was not accurate.For example, liquid within the bag will read 150 ml's when held level, but when emptied it measures 100 ml's.Per follow-up received via email on 26apr2022, it was reported that all the collections bags were the same and the bags and hanging loops were flexible therefore it was not possible to hang/hold the bags in a consistent way to ensure that a given volume read the same from nurse to nurse.Also, the bags hang very differently depending on how full they were of liquid and how much gas was in them, both of which skews an accurate reading.Customer measured 3 different amounts of water and placed each in a clean bag.In each time the markings on the bag did not correctly reflect the actual amount of water, and being off by up to 50%.

• Brand Name: BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM COLLECTION BAGS
• Common Device Name: STOOL MANAGEMENT SYSTEM COLLECTION BAGS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13935353
• Report Number: 1018233-2022-01687
• Device Sequence Number: 4131664
• Product Code: KNT
• UDI-Device Identifier: 00801741045967
• UDI-Public: (01)00801741045967
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K133251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Model Number: SMS2B1L
• Device Catalogue Number: SMS2B1L
• Device Lot Number: NGFS0411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 09/24/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown