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

Model Number	0600060
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model 0600060 chronic catheter some time post insertion, there was alleged resistance when infusing the chronic catheter.This report was received from one source.This event involved one patient whose age, weight and gender was not provided.Patient had no reported patient injury.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model 0600060 chronic catheter some time post insertion, there was alleged resistance when infusing the chronic catheter.This report was received from one source.This event involved one patient whose age, weight and gender was not provided.Patient had no reported patient injury.
Additional Manufacturer Narrative
H10: the device has been returned to the manufacturer for evaluation.The investigation is confirmed for resistance when infusing the catheter, as the catheter was initially partially patent to infusion; however, residue was subsequently dislodged and the catheter was patent to infusion with an expected observed flow-rate.The catheter was also patent to infusion against resistance and aspiration with no observable leaks.Residue was noted throughout the catheter.The definitive root cause could not be determined based upon available information.The device is 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.

• 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: 8533414
• Report Number: 3006260740-2019-01107
• Device Sequence Number: 1845948
• 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): 07/24/2019

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: HUCS2224
• 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: 07/24/2019
• Patient Sequence Number: 1