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

Catalog Number	0043650
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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.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 after about three days of use, the spring evacuator tube was cracked.
Event or Problem Description
It was reported that after about three days of use, the spring evacuator tube was cracked.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received (5) photo samples.The first photo sample shows the overview of the spring evacuator.The second and third photo shows the spring evacuator y-connector.The fourth photo shows the top view of the y-connector.The fifth photo shows the y-connector attach to the spring evacuator.Visual evaluation of the returned sample noted one opened (without original packaging), used 3-spring evacuator.Visual inspection of the sample noted no cracks present on the tubing of y-connector nor the suction evacuator.No root cause could be found because the reported event was unconfirmed.The device history record review could not be performed without a lot number.As the reported event was unconfirmed a labeling review was not required.Correction: d, h.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.

• Brand Name: CLOSED WOUND SUCTION
• Common Device Name: CLOSED WOUND SUCTION
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20831384
• Report Number: 1018233-2024-07702
• Device Sequence Number: 8585530
• Product Code: GCY
• UDI-Device Identifier: 00801741049385
• UDI-Public: (01)00801741049385
• 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): 02/14/2025

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: 0043650
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 02/15/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/25/2025
• 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