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

Catalog Number	072231
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the trocars are not sharp and it was nearly impossible for the doctor to puncture through skin using the trocars.An insane amount of force was required to use it and it causes a major safety concern for the patient as well as staff members.
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.
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 trocars are not sharp and it was nearly impossible for the doctor to puncture through skin using the trocars.An insane amount of force was required to use it and it causes a major safety concern for the patient as well as staff members.As per the mail notification received on 05apr2025, trocar was inserted in a inside to outside manner under the breast.When trying to push trocar and puncture through skin, it was not successful.Two hands, multiple tries, and a lot of force was required for the trocar to serve its purpose.A second drain was placed and a different surgeon tried the same attempt.After pushing and seeing they could potentially harm the patient or themself, they had to use a knife and a hemostat to create his own tunnel for the trocar to pass through.
Additional Manufacturer Narrative
The reported event was confirmed by capa association to be manufacturing related as per (b)(4), the root cause identified is: "the potential root cause of varying tip geometry was investigated fully.The edge radii, angle, point, length of point, profile was investigated between two different bd lots and a competitor lot.The difference between the bd lots and competitor lot showed a significant difference in the force needed to puncture the polyurethane sample in the test method draft.The analysis performed shows that the geometry profiles can make a significant difference in force needed to pierce the polyurethane sample.There were some differences between bd lots that were tested.A dhr review was not required because the investigation was confirmed by the capa association.A labeling review are not required because the investigation was confirmed by the capa association.Correction- d 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 trocars are not sharp and it was nearly impossible for the doctor to puncture through skin using the trocars.An insane amount of force was required to use it and it causes a major safety concern for the patient as well as staff members.As per the mail notification received on 05apr2025, trocar was inserted in a inside to outside manner under the breast.When trying to push trocar and puncture through skin, it was not successful.Two hands, multiple tries, and a lot of force was required for the trocar to serve its purpose.A second drain was placed and a different surgeon tried the same attempt.After pushing and seeing they could potentially harm the patient or themself, they had to use a knife and a hemostat to create his own tunnel for the trocar to pass through.

• Brand Name: CHANNEL DRAIN
• Common Device Name: CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 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: 21535411
• Report Number: 1018233-2025-01473
• Device Sequence Number: 18053118
• Product Code: GBX
• UDI-Device Identifier: 00801741049910
• UDI-Public: (01)00801741049910(11)241030(17)290831(10)NGJW1347
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 05/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 072231
• Device Lot Number: NGJW1347
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 04/05/2025; 05/14/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/10/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• 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: Required Intervention; Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 91 KG