MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. Kellywick Tunneler; Surgical other

Catalog Number	KW2000
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Section a through f: the information provide 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
On (b)(6) 2026, a patient underwent surgical procedure using a kelly wick tunneller.Prior to the procedure, it was reported that there was bent on latch and holes in the internal plastic.There was no patient contact.
Event or Problem Description
On (b)(6) 2026, a patient underwent surgical procedure using a kelly wick tunneller.Prior to the procedure, it was reported that there was bent on latch and holes in the internal plastic.There was no patient contact.
Additional Manufacturer Narrative
H11: this supplemental report is submitted to correct an error in the previously submitted reports.The initial mdr and supplemental report 1 listed an incorrect manufacturing location (g1).The correct manufacturing location for this device is bard peripheral vascular inc.No new event information is being reported in this supplement.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.G1, g3 section a through f: the information provide 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: Kellywick Tunneler
• Common Device Name: Surgical other
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): Bard Peripheral Vascular, Inc.; 1625 w 3rd st.; tempe GA 85281
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25702323
• Report Number: 2020394-2026-01712
• Device Sequence Number: 9719970
• Product Code: DWS
• UDI-Device Identifier: 00801741129452
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: Unknown
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2026

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: KW2000
• Device Lot Number: 28052606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 08/07/2026; 09/21/2026
• Initial Report FDA Received Date: 07/03/2026
• Supplement Report FDA Received Date: 08/25/2026; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown