MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UDC 8F 15CM; CHRONIC CATHETER

Catalog Number	NNU8LP15
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.Although the sample was not returned for evaluation, three electronic photos were provided for review.The investigation is confirmed for hub crack/break, as a fragment of a hub from a navarre catheter with the rest of the device missing was observed in the photos provided.The break profile had an incline and appeared to be rough and jagged.There were longitudinal splits observed that started at the distal break surface and extended proximally.The longitudinal split edges and surfaces appeared to be straight and smooth.The printing on the hub fragment appeared to be worn.The definitive root cause could not be determined based upon available information.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model nnu8lp15.Chronic catheter allegedly experienced a fluid leak.This report was received from a single source.This event did involve patient with no reported patient injury.Age, weight, and gender were not provided for the patient.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model nnu8lp15.Chronic catheter allegedly experienced a fluid leak and a crack.This report was received from a single source.This event did involve patient with no reported patient injury.Age, weight, and gender were not provided for the patient.
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.Although the sample was not returned for evaluation, three electronic photos were provided for review.The investigation is confirmed for hub crack/break, as a fragment of a hub from a navarre catheter with the rest of the device missing was observed in the photos provided.The definitive root cause could not be determined based upon available information.The device was labeled for single use.

• Brand Name: UDC 8F 15CM
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8809401
• Report Number: 3006260740-2019-02075
• Device Sequence Number: 16223380
• Product Code: GBX
• UDI-Device Identifier: 00801741036996
• UDI-Public: (01)00801741036996
• 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
• Report Date (Section B): 10/23/2019

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 Catalogue Number: NNU8LP15
• Device Lot Number: GFAZ2429
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 10/23/2019
• Patient Sequence Number: 1