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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Channel Drain; Wound Drain

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C.R. Bard Inc. (Covington) -1018233 Channel Drain; Wound Drain Back to Search Results
Catalog Number 072223
Medical Device Problem Code Failure to Capture (1081)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/25/2026
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that after a kidney transplant, a drain was placed in the donor patient after surgery.The drain doesn't show up on the x ray and wanted to check if there was something wrong with the product.As usual, took the images with the fujifilm carneo go plus.The patient was a 75 year old woman and not obese.The device was still in place.Typically, a postoperative drainage tube would be visible in the image.Health professional plan to retrieve the device later if possible; for now, need to investigate whether any similar incidents have occurred with this specific lot.
 
Additional Manufacturer Narrative
The initial reporter's phone number:(b)(6).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: 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.
 
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Brand Name
Channel Drain
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
+1(770)784-6100
MDR Report Key50482356
Report Number1018233-2026-05612
Device Sequence Number13296053
Product Code GBX
UDI-Device Identifier00801741049842
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
Exempt
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Other,User Facility
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 09/18/2026
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 Number072223
Device Lot NumberNGKS3120
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 08/25/2026
Supplement Date Received by Manufacturer09/10/2026
09/18/2026
Initial Report FDA Received Date08/27/2026
Supplement Report FDA Received Date09/11/2026
09/23/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured06/12/2025
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 Number1
Outcome Attributed to Adverse Event Other;
Patient Age75 YR
Patient SexFemale
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