MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SEEKER; SUPPORT CATHETER

Model Number	SK13535M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunctions were provided and a lot history review was performed.All six devices, three of which were lot samples, were returned to bd for evaluation.The investigation is identified for two of the malfunctions and no break identified for the remaining four malfunctions.Based on the information provided, the definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes six malfunction's.A review of the reported information indicated that model sk13535m support catheter allegedly experienced a break.This information was received from various sources.All the malfunctions involved a patient with no consequences.One patient was a (b)(6) male.The remaining patient's age, weight and gender were not provided.

• Brand Name: SEEKER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9963751
• Report Number: 2020394-2020-02726
• Device Sequence Number: 2546595
• Product Code: DQY
• UDI-Device Identifier: 00801741067891
• UDI-Public: (01)00801741067891
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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: No Information
• Device Model Number: SK13535M
• Device Catalogue Number: SK13535M
• Device Lot Number: VTDV0555, VTCX0063
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1