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

Model Number	N/A
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 rebu0691 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Reported by facility that this picc was placed (b)(6) 2017, removed (b)(6) 2017 because of kinks in catheter and a break at the hub of the purple lumen hub.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a break in the extension leg tubing 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 purple extension leg near the distal end of the luer connector.Both lumens of the sample were flushed and pressurized with a 12 ml syringe of water.The red lumen was found to be patent to infusion and aspiration and no leaks were found when the lumen was pressurized; however, leakage was observed emanating from the split in the tubing of the purple lumen.A microscopic observation revealed several beach marks and cracks on the break surface of the purple lumen, which are suggestive of material fatigue.The tubing material 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.The beginning of a split was observed in the tubing of the red lumen and cracks similar to those observed on the purple lumen were observed on the break surface of the beginning of a split in the red lumen.An internal investigation is currently ongoing to determine the root cause of this splitting; reference (b)(4) for further information.A lot history review (lhr) of rebu0691 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Reported by facility that this picc was placed (b)(6) 2017, removed (b)(6) 2017 because of kinks in catheter and a break at the hub of the purple lumen hub.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a break in the extension leg tubing 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 purple extension leg near the distal end of the luer connector.Both lumens of the sample were flushed and pressurized with a 12 ml syringe of water.The red lumen was found to be patent to infusion and aspiration and no leaks were found when the lumen was pressurized; however, leakage was observed emanating from the split in the tubing of the purple lumen.A microscopic observation revealed several beach marks and cracks on the break surface of the purple lumen, which are suggestive of material fatigue.The tubing material 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.The beginning of a split was observed in the tubing of the red lumen and cracks similar to those observed on the purple lumen were observed on the break surface of the beginning of a split in the red lumen.An internal investigation is currently ongoing to determine the root cause of this splitting; reference (b)(4) for further information.A lot history review (lhr) of rebu0691 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Reported by facility that this picc was placed (b)(6) 2017, removed (b)(6) 2017 because of kinks in catheter and a break at the hub of the purple lumen hub.

• Brand Name: DOT PROV 4F DL MAX 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: 6945853
• Report Number: 3006260740-2017-01830
• Device Sequence Number: 1460444
• 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: user facility
• Initial Reporter Occupation: Other
• 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 Model Number: N/A
• Device Catalogue Number: S9274108D
• Device Lot Number: REBU0691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 09/28/2017; 12/28/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 11/01/2017; 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1