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

Model Number	SK15035M
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 numbers were provided for the two malfunctions and a lot history review will be performed.The device was returned for one of the malfunctions, and the other returned a photo only.The investigations are currently underway.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunction.A review of the malfunctions indicated that model sk15035m support catheter allegedly experienced a break.This information was received from various sources.One of the malfunctions involved a female patient with no reported consequences.No other patient information was provided.
Event or Problem Description
This report summarizes two malfunctions.A review of the malfunctions indicated that model sk15035m support catheter allegedly experienced a break.This information was received from various sources.One of the malfunctions involved a female patient with no reported consequences.No other patient information was provided.
Additional Manufacturer Narrative
H10: the lot numbers were provided for the two malfunctions and a lot history review will be performed.The device was returned for one of the malfunctions, and the other returned a photo only.The investigation is confirmed for one complaint as break and the photo review is still pending.The devices are labeled for single use.H11:section a through f - the information provided by bd represents all of 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
H10: the lot numbers were provided for the two malfunctions and a lot history review was performed.The device was returned for one of the malfunctions therefore,the investigation is confirmed for one complaint as break.For another malfunctions the investigation is inconclusive for break.Based on the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.H11:section a through f - the information provided by bd represents all of 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
This report summarizes two malfunctions.A review of the malfunctions indicated that model sk15035m support catheter allegedly experienced a break.This information was received from various sources.One of the malfunctions involved a female patient with no reported consequences.No other patient information was 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: 9963907
• Report Number: 2020394-2020-02729
• Device Sequence Number: 11399564
• Product Code: DQY
• UDI-Device Identifier: 00801741067921
• UDI-Public: (01)00801741067921
• 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,Followup,Followup
• Report Date (Section B): 10/14/2020

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: SK15035M
• Device Catalogue Number: SK15035M
• Device Lot Number: VTDX0338, VTDU0295
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 09/30/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/17/2020; 10/14/2020
• Patient Sequence Number: 1