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

Catalog Number	0071440
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
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 wound drainage had a malfunction 10mm jp drain.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: indications for use: wound drains are used to remove exudates from wound sites.A.Drain placement 1.Place wound drain(s) within critical fluid collection areas.2.Draw non-perforated section of wound drain through skin until flat portion of drain is seated appropriately or drain indicator mark appears at the skin surface.3.Attach non-perforated section of drain either to davol y-connector or directly to evacuator inlet port.Note: (1) since the 1/8 silicone round drain cannot connect directly to the evacuator inlet port, bd davol #0070780 y-connector must be used to connect to evacuator.(2) when using two drains, the bd davol #0070790 y-connector must also be used with 3/16, 1/4 silicone round drains and 7, 10 and 12.7 mm silicone flat drains.4.With two silicone drains; cut off plug from closed arm of y-connector.Attach both drains to y-connector and then attach y-connector to inlet port.Caution: do not puncture or perforate drain.B.To establish suction in evacuator 1.Open capped port.2.Squeeze evacuator.3.Close empty port.Orient plug strap so that plug tab does not contact inlet port.C.To empty container 1.Open capped port over collection basin.2.Squeeze evacuator to empty.D.To re-establish suction 1.Repeat step b above.E.To read fluid volume 1.Open capped port to release vacuum.2.Read and record approximate volume.3.Empty and reactivate evacuator.Important: a.Check for fluid entering closed wound suction evacuator.Lack of flow may indicate all exudate has been removed.Check all connections for air leaks and wound tube perforations for exposure above skin.B.Several activations of the closed wound suction evacuator may be required to establish suction because of: -air entering partially closed wound.An operative air pocket.C.The attached strap may be used to secure the evacuator to the patient.Precautions: 1.Avoid suturing through the drains to minimize the possibility of breakage.2.Drains should lie flat and in line with the skin exit path.3.Particular care should be taken to avoid any obstacles to the drain exit path.4.Drains should be checked for free motion during closure to minimize the possibility of breakage during/after removal.5.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or blunt instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Warning: drain breakage may require surgical removal.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 wound drainage had a malfunction 10mm jp drain.

• 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: 21881857
• Report Number: 1018233-2025-02863
• Device Sequence Number: 20990433
• Product Code: GCY
• UDI-Device Identifier: 00801741049675
• UDI-Public: (01)00801741049675(11)241023(17)290630(10)NGJU2668
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: 0071440
• Device Lot Number: NGJU2668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• 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