MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV SP 3F SL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S1173108PD
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebw1843 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that they found a leak due to a crack near the hub.It was stated that this has occurred with four patients.No patient details available at this time; date of occurrence was not reported.No injury to the patients were reported.This file is for the first of the four events reported.
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 3 fr single lumen powerpicc provena was returned for evaluation.An initial visual observation showed use residue throughout the returned sample.A large split was observed in the extension tubing just within the distal end of the luer connector.The sample was flushed and pressurized with a 12 ml syringe of water and was found to be patent to infusion and aspiration.A leak was observed emanating from the large split in the extension tubing.A microscopic observation revealed the fracture surface of the split in the extension tubing was rough and exhibited cracks/fissures and beach marks, which are indicative 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.An internal investigation is currently ongoing to determine the root cause of this cracking.A lot history review (lhr) of rebw1843 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that they found a leak due to a crack near the hub.It was stated that this has occurred with four patients.No patient details available at this time; date of occurrence was not reported.No injury to the patients were reported.This file is for the first of the four events reported.

• Brand Name: DOT PROV SP 3F SL MAX
• 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: 7261412
• Report Number: 3006260740-2018-00181
• Device Sequence Number: 11288609
• Product Code: LJS
• UDI-Device Identifier: 00801741134104
• UDI-Public: (01)00801741134104
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall,Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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: S1173108PD
• Device Lot Number: REBW1843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1