MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN, 12.5" (31.7CM) HOLE PATTERN, TROCAR

Model Number	0043630
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the connector of the evacuator was loose and it was unable to connect on the day of use.
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 connector of the evacuator was loose and it was unable to connect on the day of use.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was used for patient treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used y-connector and an unused round drain tubing visual inspection of the sample noted the y-connector and round drain tubing was connected to the in-house evacuator and squeezed to negative pressure with the (in-house) evacuator and placed in a reservoir of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the solution was returned into the evacuator as intended with no disconnection from the drain tubing.No fitting issues observed.Photo sample was returned and could not be evaluated for the reported failure.The device history record review could not be performed without a lot number.As the reported event is unconfirmed a labeling review is not required.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was evaluated.

• Brand Name: CWS 400 CLOSED WOUND SUCTION KIT, PVC DRAIN, 12.5" (31.7CM) HOLE PATTERN, TROCAR
• Common Device Name: CLOSED WOUND SUCTION KIT
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15002792
• Report Number: 1018233-2022-05400
• Device Sequence Number: 1737929
• Product Code: GCY
• UDI-Device Identifier: 00801741049378
• UDI-Public: (01)00801741049378
• 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): 01/06/2023

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: 0043630
• Device Catalogue Number: 0043630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 01/07/2023
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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