MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 19FR RND 3/4 FLUTE W/TRO; CHANNEL DRAIN

Catalog Number	072225
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/28/2023
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 until then, the 19fr channel drain could be connected to a 5mm abdominal port without any problem, but that time it could not be connected.Per follow up information received via ibc on 10oct2023, the customer confirmed that it was a fitting problem.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product had not caused the reported failure.Visual inspection of the sample noted attached the drain to the evacuator and applied negative pressure in reservoir of 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the solution return into the silicone bulb evacuator as intended.No fitting problems observed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.As the reported event is unconfirmed a labeling review is not required.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 until then, the 19fr channel drain could be connected to a 5mm abdominal port without any problem, but that time it could not be connected.Per follow up information received via ibc on (b)(6) 2023, the customer confirmed that it was a fitting problem.

• Brand Name: 19FR RND 3/4 FLUTE W/TRO
• 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: 17940695
• Report Number: 1018233-2023-07484
• Device Sequence Number: 6311835
• Product Code: GBX
• UDI-Device Identifier: 00801741049859
• UDI-Public: (01)00801741049859
• 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): 01/24/2024

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: 072225
• Device Lot Number: NGGZ2613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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