MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROV 3F SL IR 70CM NI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S3173355
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) review is not possible, as no manufacturing lot number has been provided by the complainant.(b)(4).
Event or Problem Description
It was reported that the patient's picc was "complicated by a fracture of an external component, requiring replacement.".No patient injury reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed.One 3 fr sl power picc catheter was returned for investigation.The catheter appeared to have been trimmed 1 cm from the distal end of the molded wing.The catheter was flushed with water using a 12 ml syringe and a leak was observed at the hub/extension tubing interface.Microscopic observation revealed a partial split in the extension tubing.The fracture surface of the split was rough and exhibited cracks/fissures and beach marks, which are indicative of material fatigue.
Event or Problem Description
It was reported that the patient's picc was "complicated by a fracture of an external component, requiring replacement." no patient injury reported.

• Brand Name: PROV 3F SL 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: 7403714
• Report Number: 3006260740-2018-00636
• Device Sequence Number: 1456345
• Product Code: LJS
• UDI-Device Identifier: 00801741129971
• UDI-Public: (01)00801741129971
• 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: Other Health Care Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019
• 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: S3173355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 MO