MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV 4F DL MAX TLS; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	S9274108D
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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of rebq2477 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported to the sales rep from the facility that the provena picc leaked just below the hub on the purple tubing of the extension leg.The picc was removed.
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; however the cause is unknown and an internal investigation is currently ongoing to determine the root cause.One 4 fr dual lumen powerpicc provena was returned for evaluation.An initial visual observation showed use residue throughout the sample.A large split was observed in the extension tubing of the purple lumen just within the distal end of the luer connector.Both lumens of the sample were flushed and pressurized with a 12 ml syringe of water.No leaks were found in the red lumen; however a leak was observed emanating from the split observed 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 the purple lumen 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; reference (b)(4) for further information.A lot history review (lhr) of rebq2477 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported to the sales rep from the facility that the provena picc leaked just below the hub on the purple tubing of the extension leg.The picc was removed.
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; however the cause is unknown and an internal investigation is currently ongoing to determine the root cause.One 4 fr dual lumen powerpicc provena was returned for evaluation.An initial visual observation showed use residue throughout the sample.A large split was observed in the extension tubing of the purple lumen just within the distal end of the luer connector.Both lumens of the sample were flushed and pressurized with a 12 ml syringe of water.No leaks were found in the red lumen; however a leak was observed emanating from the split observed 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 the purple lumen 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; reference (b)(4) for further information.A lot history review (lhr) of rebq2477 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported to the sales rep from the facility that the provena picc leaked just below the hub on the purple tubing of the extension leg.The picc was removed.

• Brand Name: DOT PROV 4F DL MAX TLS
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7001458
• Report Number: 3006260740-2017-01971
• Device Sequence Number: 19269964
• Product Code: LJS
• UDI-Device Identifier: 00801741130441
• UDI-Public: (01)00801741130441
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2018

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: S9274108D
• Device Lot Number: REBQ2477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 11/16/2017; 12/28/2017
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 01/09/2018; 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1