MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROV 4.2FR S/L; CHRONIC CATHETER

Model Number	0600060
Medical Device Problem Codes	Break (1069); Defective Component (2292)
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 600060 chronic catheter experienced a break.This report was received from one source.Of this event, the device was used on the patient with no reported injury.The patient¿s age, sex, and weight were not provided.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 600060 chronic catheter experienced a break.This report was received from one source.Of this event, the device was used on the patient with no reported injury.The patient¿s age, sex, and weight were not provided.
Additional Manufacturer Narrative
The lot number for the device was provided and the lot history review was performed.One 4.2fr broviac catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for complete break in outer protective sleeve, as the outer protective sleeve of the catheter had a complete break just distal to the clamping oversleeve.The separation surfaces of the outer lumen were observed to be uneven and partially rough.Additionally, the break profile had a sharp incline.These observations are consistent with breaks/tears caused by repeated and/or prolonged lumen exposure to excessive mechanical stresses.A longitudinal split was observed after the tape was removed, distal to the hub.The split surface was observed to be smooth.The observed split is consistent with damage caused by manipulating the device with sharp instruments/tools.No damage on the inner lumen was observed; no leaks were observed at the break or at the split.The device is labeled for single use.(b)(4).

• Brand Name: BROV 4.2FR S/L
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8528896
• Report Number: 3006260740-2019-00984
• Device Sequence Number: 2758594
• Product Code: LJS
• UDI-Device Identifier: 00801741051692
• UDI-Public: (01)00801741051692
• 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: 0600060
• Device Catalogue Number: 0600060
• Device Lot Number: HUBX0591
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1