MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROV 4F DL IR 70CM NI; 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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recy7968 showed ten other similar product complaint(s) from this lot number.The complaints for this lot number (recy7968) have been reported from the same facility.
Event or Problem Description
It was reported that 3 provena piccs were occluded in the bone marrow transplant unit, in the middle of stem cell infusions.It was stated that the piccs were unable to be cathflo'd successfully.No other information is available.This report addresses the first picc.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an occluded catheter was inconclusive due to non-original product sample return.One sealed 4 fr dl powerpicc provena catheter kit was returned for investigation with lot: recy7968.The catheter was flushed with water using a 12 ml syringe and was patent to infusion.The catheter was cut near the 10 cm depth marker.The wall thickness, outer diameter, and lumen were measured and found to be within specification.Since no issues were observed on the returned sealed sample, the complaint could not be confirmed.Based on the description of the reported event, possible contributing factors include catheter kinking and catheter maintenance.The product ifu states, "avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort" and "flush each lumen of the catheter with 10 ml of sterile saline every 12 hours or after each use.Use a 10 ml or larger syringe.2.In addition, lock each lumen of the catheter with heparin flush solution.Usually, 1 ml per lumen is adequate." a lot history review (lhr) of recy7968 showed ten other similar product complaint(s) from this lot number.The complaints for this lot number (recy7968) have been reported from the same facility.
Event or Problem Description
It was reported that 3 provena piccs were occluded in the bone marrow transplant unit, in the middle of stem cell infusions.It was stated that the piccs were unable to be cathflo'd successfully.No other information is available.This report addresses the first picc.

• Brand Name: PROV 4F DL IR 70CM NI
• 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: 8777855
• Report Number: 3006260740-2019-01905
• Device Sequence Number: 11429355
• Product Code: LJS
• UDI-Device Identifier: 00801741130052
• UDI-Public: (01)00801741130052
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

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: S3274355
• Device Lot Number: RECY7968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1