MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CHANNEL DRAIN

Catalog Number	072221
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/30/2024
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.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 during channel drain placement, the needle was no longer sharp and does not penetrate the skin well, so a scalpel incision was necessary.The cross-section of the penetration part was dirty, so the tube falls out from the needle when the tube was pulled out.
Additional Manufacturer Narrative
The reported event was unconfirmed.Three photos were received for evaluation, the first one shows the trocar with protective sleeve, no drain attached.The next two photos show the trocar tip and edges.Also received trocar with no drain attached, evidence of drain present but not attached.The trocar appears sharp, unconfirmed.No root cause could be found because the reported event was unconfirmed.As the reported event is unconfirmed a dhr review is not required.As the reported event is unconfirmed a labeling review is not required.Udi format updated with available product information per gudid.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 during channel drain placement, the needle was no longer sharp and does not penetrate the skin well, so a scalpel incision was necessary.The cross-section of the penetration part was dirty, so the tube falls out from the needle when the tube was pulled out.

• Brand Name: CHANNEL DRAIN
• Common Device Name: CHANNEL DRAIN
• 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: 19358141
• Report Number: 1018233-2024-02843
• Device Sequence Number: 15078061
• Product Code: GBX
• UDI-Device Identifier: 00801741049835
• UDI-Public: (01)00801741049835(11)230821(17)280531(10)NGHT2760
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 072221
• Device Lot Number: NGHT2760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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