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

Catalog Number	S3274355
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rebu0083 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
It was reported that the patient's right upper extremity picc was malfunctioning.No patient injury reported.

• Brand Name: PROV 4F DL IR 70CM NI
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7403708
• Report Number: 3006260740-2018-00637
• Device Sequence Number: 10795239
• Product Code: LJS
• UDI-Device Identifier: 00801741130052
• UDI-Public: (01)00801741130052
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Notification
• Type of Report: Initial
• Report Date (Section B): 04/06/2018
• Report Date (Section F): 03/14/2018

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: Health Professional
• Device Catalogue Number: S3274355
• Device Lot Number: REBU0083
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR