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

Model Number	0006510
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the dignisheild manual was reviewed and customer wants to find information about what should be done if there is a tear in the rectal tube.Asking is it advised that the area be patched up or should a new one be placed?.Also stated that if there is tear would it compromise the balloon retention.
Event or Problem Description
It was reported that the dignisheild manual was reviewed and customer wants to find information about what should be done if there is a tear in the rectal tube.Asking is it advised that the area be patched up or should a new one be placed.Also stated that if there is tear would it compromise the balloon retention.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "missing instructions ".It was unknown whether the device had met specifications.Based on patient code (b)(6) the product does not appear to have been used.However, the product is intended to be used for treatment purpose but it is unknown if there is a relationship between the reported event and the device.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the dignisheild ifus are found to be adequate based on past reviews.Correction: d.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.

• Brand Name: UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
• Common Device Name: UNKNOWN DIGNISHIELD
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12453181
• Report Number: 1018233-2021-05565
• Device Sequence Number: 11600560
• Product Code: KNT
• UDI-Device Identifier: 00801741045974
• UDI-Public: (01)00801741045974
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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: Health Professional
• Device Model Number: 0006510
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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