MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® RECTAL TUBE; BARD RECTAL TUBE

Model Number	0006510
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
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 dignishield manual was reviewed and customer wanted to find information about what should be done if there was a tear in the rectal tube.Also asked was it advised that the area be patched up or should a new one be placed? also stated that, if there was tear would it compromise the balloon retention.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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 or Problem Description
It was reported that the dignishield manual was reviewed and customer wanted to find information about what should be done if there was a tear in the rectal tube.Also asked was it advised that the area be patched up or should a new one be placed? also stated that, if there was tear would it compromise the balloon retention.

• Brand Name: BARD® RECTAL TUBE
• Common Device Name: BARD RECTAL TUBE
• 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: 12441291
• Report Number: 1018233-2021-05510
• Device Sequence Number: 17116385
• 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): 11/30/2021

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: 0006510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 12/10/2021
• 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