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

Catalog Number	072221
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd 10fr round drains.We opened 3 different packages of sterile drains, and all were unusable.They had fuzzy sticky stuff on drains, and the third one had fuzzy substance and a hair inside the sterile packaging.Reference number 072221.All (3 packages) had same lot number: ngkp0821.Surgeon has had several issues with 10f drains for a while across all operating rooms ld, bl, bw.1.We are finding debris, powder- like substance on them.2.Very often the drains have small white pieces of plastic that are stuck to the clear portion of the drain.It is so frequent that surgeon has the staff check the tubing before we insert them.According to some, they see this across drain sizes.Not sure if something in the manufacturing changed.3.There have been two times that the drains did not function at the end of the case.After investigating, the same clear jell that is at the end of the drain by the trocar was filling the fluted part of the drain as well so it was not able to hold suction.Surgeon is having staff flush all the drains now before placement and close the incision, so we know they function.Emi has four drains that she is sending to product defect today [date redacted].Bd 10fr round drains ref.072221 ngjw3604.Patient here for surgery.Surgeon always uses two 10fr round drains.Opened two drains at beginning of case, both drains had fuzzy material on the drain in the sterile packaging.This has happened before.Surgeon switched and had to use 15fr drains which showed no contamination.Bd 10fr round drains.Ref 072221.Ngkp0821.Bl or drain issues - surgical drain bulbs had debris in them.These ranged from hair to black specs and other unidentifiable objects.Lot-nghz0309, lot-ngkq2776, lot-ngjw3939, and lot-ngkq0974.
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: 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.
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.A labeling review was not performed because labeling could not have prevented the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections: d, 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.
Event or Problem Description
It was reported that the bd 10fr round drains.We opened 3 different packages of sterile drains and all were unusable.They had fuzzy sticky stuff on drains and the third one had fuzzy substance and a hair inside the sterile packaging.Reference number (b)(4).All (3 packages) had same lot number: ngkp0821.Surgeon has had several issues with 10f drains for a while across all operating rooms ld, bl, bw.1.We are finding debris, powder- like substance on them.2.Very often the drains have small white pieces of plastic that are stuck to the clear portion of the drain.It is so frequent that surgeon has the staff check the tubing before we insert them.According to some, they see this across drain sizes.Not sure if something in the manufacturing changed.3.There have been two times that the drains did not function at the end of the case.After investigating, the same clear jell that is at the end of the drain by the trocar was filling the fluted part of the drain as well so it was not able to hold suction.Surgeon is having staff flush all the drains now before placement and close the incision, so we know they function.(b)(6) has four drains that she is sending to product defect today [date redacted].Bd 10fr round drains ref.(b)(4).Patient here for surgery.Surgeon always uses two 10fr round drains.Opened two drains at beginning of case, both drains had fuzzy material on the drain in the sterile packaging.This has happened before.Surgeon switched and had to use 15fr drains which showed no contamination.Bd 10fr round drains.Ref (b)(4).Bl or drain issues - surgical drain bulbs had debris in them.These ranged from hair to black specs and other unidentifiable objects.(lot-nghz0309), (lot-ngkq2776), (lot-ngjw3939), and (lot-ngkq0974).

• 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 ; 7707846100
• MDR Report Key: 23084139
• Report Number: 1018233-2025-08302
• Device Sequence Number: 20030183
• Product Code: GBX
• UDI-Device Identifier: 00801741049835
• UDI-Public: (01)00801741049835(11)250313(17)300130(10)NGKP0821
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 072221
• Device Lot Number: NGKP0821
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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 Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown