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

Catalog Number	S9274118
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 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; however the cause is unknown and an internal investigation is currently ongoing to determine the root cause.One 4 fr dual lumen power picc provena was returned for evaluation.An initial visual observation showed use residue throughout the sample and the ink on the extension legs was observed to be worn and faded.A split was observed in the extension tubing of the purple lumen just within the distal end of the luer connector.Both lumens of both catheter segments were flushed with a 12 ml syringe of water.A leak was observed emanating from the split in the extension tubing of the purple lumen.A microscopic observation revealed the fracture surface of the split in the extension tubing of the purple lumen was rough and exhibited cracks/fissures and beach marks, which are indicative of material fatigue.The tubing material of both the purple and red lumens was observed to be attached to the luer connector at irregular points along the tubing¿s circumference, and cracking appeared to have initiated at one or more of these points.An internal investigation is currently ongoing to determine the root cause of this cracking.A lot history review (lhr) of rebu0002 showed one other similar product complaints from this lot number.
Event or Problem Description
It was reported that the provena leaked at the hub.There was no reported patient injury.

• Brand Name: PROV 4F DL BASIC TLS
• 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: 7441889
• Report Number: 3006260740-2018-00739
• Device Sequence Number: 13966337
• Product Code: LJS
• UDI-Device Identifier: 00801741130328
• UDI-Public: (01)00801741130328
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Recall
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: S9274118
• Device Lot Number: REBU0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1