MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROV 4F DL IR 70CM NI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recy7968 showed ten other similar product complaint(s) from this lot number.The complaints for this lot number (recy7968) have been reported from the same facility.

Event Description

It was reported that 3 provena piccs were occluded in the bone marrow transplant unit, in the middle of stem cell infusions.It was stated that the piccs were unable to be cathflo'd successfully.No other information is available.This report addresses the third picc.

• Brand Name: PROV 4F DL IR 70CM NI
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8777876
• MDR Text Key: 150696698
• Report Number: 3006260740-2019-01908
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741130052
• UDI-Public: (01)00801741130052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S3274355
• Device Lot Number: RECY7968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1