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

Device Problem Inflation Problem (1310)

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

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.H3 other text : the device was not returned.

Event Description

It was reported that dignishield balloon for fecal management system would not inflate on 2 separate systems with same lot number.Nurse could not place device.Per additional information received via email on 28mar2024, it was reported that no water was able to go into the balloon.The water stopped at the green squishy piece and there was no visible damage noticed on the device and there was no impact or injury to the patient, it was an extremely long process, and they were trying to insert the rectal tube with three separate devices on a patient who was alert and aware.

Manufacturer Narrative

The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿occluded lumen punctured lumen".However, there was insufficient information to confirm this potential root cause.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.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 Description

It was reported that dignishield balloon for fecal management system would not inflate on 2 separate systems with same lot number.Nurse could not place device.Per additional information received via email on 28mar2024, it was reported that no water was able to go into the balloon.The water stopped at the green squishy piece and there was no visible damage noticed on the device and there was no impact or injury to the patient, it was an extremely long process, and they were trying to insert the rectal tube with three separate devices on a patient who was alert and aware.Per sample received on 15apr2024, it was noted that the two additional used samples were returned for evaluation.Per clarification of the previous follow up customer email, no issues were noted with the samples that the customer provided.They came from the same lot nghw4441, and the customer sent them in for evaluation.The specific device that would not inflate and accept any water was not available for a return sample.

• Brand Name: UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
• Type of Device: 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19115278
• MDR Text Key: 340268527
• Report Number: 1018233-2024-02111
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/23/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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