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

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 evaluate.Results are expected soon.A lot history review (lhr) of rebr1401 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by facility that when the picc was flushed, it leaked and sprays at the junction of the purple lumen and catheter line (purple lumen below the hub).The cleaning solution used on the catheter was chlorhexidine 2 or 4 %.No other information is available.
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.One photograph and one video of the proximal end of what appears to be a 4 fr dual lumen powerpicc provena was returned for evaluation.An initial visual observation of the photograph showed blood residue in the extension tubing of the purple lumen and the clamp of on the extension tubing of the red lumen was engaged.The returned video of the sample showed a weeping leak that appeared to be emanating from the distal end of the luer connector of the purple lumen.No holes or splits could be seen.While the exact cause of the leak shown in the returned video is unknown, possible contributing factors include sharp instrument damage, material fatigue, and tensile failure.A lot history review (lhr) of rebr1401 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by facility that when the picc was flushed, it leaked and sprays at the junction of the purple lumen and catheter line (purple lumen below the hub).The cleaning solution used on the catheter was chlorhexidine 2 or 4 %.No other information is available.
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.One photograph and one video of the proximal end of what appears to be a 4 fr dual lumen powerpicc provena was returned for evaluation.An initial visual observation of the photograph showed blood residue in the extension tubing of the purple lumen and the clamp of on the extension tubing of the red lumen was engaged.The returned video of the sample showed a weeping leak that appeared to be emanating from the distal end of the luer connector of the purple lumen.No holes or splits could be seen.While the exact cause of the leak shown in the returned video is unknown, possible contributing factors include sharp instrument damage, material fatigue, and tensile failure.A lot history review (lhr) of rebr1401 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by facility that when the picc was flushed, it leaked and sprays at the junction of the purple lumen and catheter line (purple lumen below the hub).The cleaning solution used on the catheter was chlorhexidine 2 or 4 %.No other information is available.

• Brand Name: DOT PROV SP 4F DL MAX
• 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: 6895077
• Report Number: 3006260740-2017-01704
• Device Sequence Number: 11058530
• Product Code: LJS
• UDI-Device Identifier: 00801741134326
• UDI-Public: (01)00801741134326
• 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): 02/09/2018

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: S3274108PD
• Device Lot Number: REBR1401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/02/2017; 12/28/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 10/31/2017; 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1