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

Catalog Number	0043650
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
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 the following two problems had occurred in the spring evacuator.Spring evacuator expands even though it was clamped.Leaks were occurring from the crimped part at the end.Per follow up information received via ibc on 02apr2025, customer confirmed that patient involvement.
Event or Problem Description
It was reported that the following two problems had occurred in the spring evacuator.Spring evacuator expands even though it was clamped.Leaks were occurring from the crimped part at the end.Per follow up information received via ibc on 02apr2025, customer confirmed that patient involvement.
Additional Manufacturer Narrative
The initial reporter's facility name: (b)(6).The reported event is confirmed cause unknown.Visual: received 1 evacuator with tubing and syringe in opened packaging.Verified material number 0043650 and batch number ngjs4281.No physical defects present.Further testing required.Visual evaluation of the returned seven-photo sample noted one opened (without original packaging), used 3-spring closed wound suction evacuator.Visual inspection of the first photo sample noted an overview of the 3-spring, drain and syringe.The second photo shows the front view of the 3-spring evacuator.The third and fourth photo shows the side view of the 3-spring evacuator.The fifth and sixth photo shows the overview of the drain.The seventh photo shows the product packaging with the product information.Functional: suction functionality was tested with returned evacuator.Excess air was removed from evacuator by flattening evacuator and closing port b.Tubing was connected to port a and open end of tubing was submerged in a beaker filled with di water and 20 ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and a crack/hole was found on the evacuator and a hole at the bottom edge.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: d, e, f, h.Udi format updated with available product information per gudid.H11: sections 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: WOUND DRAIN
• 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, GA 30014 ; 7707846100
• MDR Report Key: 21882322
• Report Number: 1018233-2025-02889
• Device Sequence Number: 8640772
• Product Code: GCY
• UDI-Device Identifier: 00801741049385
• UDI-Public: (01)00801741049385(11)240706(17)290430(10)NGJS4281
• 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): 02/06/2026

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
• Device Lot Number: NGJS4281
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2024
• 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