MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TRIFUSION 23CM, INTER; CHRONIC CATHETER

Model Number	0609230
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 0609230 chronic catheter experienced a missing component.This report was received from a single source.Of the one event, one patient was involved with no reported patient injury.The patient's age, weight and gender were not provided.
Additional Manufacturer Narrative
H.10.For the reported event, lot number was provided, and lot history review.The sample was not returned for evaluation.The medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged missing component as no objective evidence has been provided to confirm any alleged deficiency with the kit.The root cause could not be determined based upon available information.The device was labeled for single use.H10: g4 h11: b5, h6 (results, conclusion) 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 one malfunction event.A review of the event indicated that model 0609230 chronic catheter allegedly experienced a missing component.This report was received from a single source.Of the one event, one patient was involved with no reported patient injury.The patient's age, weight and gender were not provided.

• Brand Name: TRIFUSION 23CM, INTER
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8532860
• Report Number: 3006260740-2019-01073
• Device Sequence Number: 19235491
• Product Code: LJS
• UDI-Device Identifier: 00801741036538
• UDI-Public: (01)00801741036538
• 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): 07/26/2019

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 Model Number: 0609230
• Device Catalogue Number: 0609230
• Device Lot Number: RECX0648
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1