MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROVENA PPICC, 4F DL, FULL 3CG; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2017
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 evaluate.Results are expected soon.A lot history review (lhr) of rebt0682 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported that the provena catheter leaked from a pinhole between the hub and tubing.The line was removed.There was no harm to the patient.
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 split 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 split was observed in the extension tubing of the red 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 purple lumen; however, a leak was observed emanating from the split in the extension tubing of the red lumen during pressurization.A microscopic observation revealed the fracture surfaces of the split in the extension tubing of the red lumen were mostly rough and exhibited cracks/fissures and some beach marks, which are indicative of material fatigue.The tubing material of the red and purple lumens were 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 in the red lumen.An internal investigation is currently ongoing to determine the root cause of this cracking.A lot history review (lhr) of rebt0682 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported that the provena catheter leaked from a pinhole between the hub and tubing.The line was removed.There was no harm to the patient.
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 split 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 split was observed in the extension tubing of the red 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 purple lumen; however, a leak was observed emanating from the split in the extension tubing of the red lumen during pressurization.A microscopic observation revealed the fracture surfaces of the split in the extension tubing of the red lumen were mostly rough and exhibited cracks/fissures and some beach marks, which are indicative of material fatigue.The tubing material of the red and purple lumens were 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 in the red lumen.An internal investigation is currently ongoing to determine the root cause of this cracking.A lot history review (lhr) of rebt0682 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported that the provena catheter leaked from a pinhole between the hub and tubing.The line was removed.There was no harm to the patient.

• Brand Name: PROVENA PPICC, 4F DL, FULL 3CG
• 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: 6993882
• Report Number: 3006260740-2017-01941
• Device Sequence Number: 1005208
• Product Code: LJS
• UDI-Device Identifier: 00801741130120
• UDI-Public: (01)00801741130120
• 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2018

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: S1274108
• Device Lot Number: REBT0682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 11/16/2017; 12/28/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 01/09/2018; 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1