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

Model Number 0006510

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

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 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 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.

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)
• Type of Device: 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
• MDR Text Key: 270807586
• Report Number: 1018233-2021-05565
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741045974
• UDI-Public: (01)00801741045974
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0006510
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other