MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CLOSED WOUND SUCTION

Catalog Number	0043600
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
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 the y connector of the suction evacuator was damaged.During use, suction was not applied, and air was leaking.The user asked to check whether the connector had a hole.As per information mentioned in the internal bd comments on (b)(6) 2023, stated that the connection between the main unit and the tube was loose and wobbly and seemed to be coming off.The y-shaped part was normal, one side had a hole and the other side was closed.They could not see any damage.
Event or Problem Description
It was reported the y connector of the suction evacuator was damaged.During use, suction was not applied, and air was leaking.The user asked to check whether the connector had a hole.As per information mentioned in the internal bd comments on 02oct2023, stated that the connection between the main unit and the tube was loose and wobbly and seemed to be coming off.The y-shaped part was normal, one side had a hole and the other side was closed.They could not see any damage.
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 evaluation of the returned sample noted one opened (with original packaging), 3 spring evacuator.Visual inspection of the sample noted no visual defects noted and the y connector was submerged in the methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) reservoir and suction applied.The evacuator suctioned as intended with no leaks or issues.No root cause could be found because the reported event was unconfirmed.The device history record is not required since the reported failure was unconfirmed.As the reported event is unconfirmed a labeling review is not required.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 actual/suspected device was inspected.

• Brand Name: CLOSED WOUND SUCTION
• Common Device Name: CLOSED WOUND SUCTION
• 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: 17948993
• Report Number: 1018233-2023-07497
• Device Sequence Number: 20533117
• Product Code: GCY
• UDI-Device Identifier: 00801741049347
• UDI-Public: (01)00801741049347
• 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): 01/10/2024

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: 0043600
• Device Lot Number: NGGZ0882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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