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 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 and an internal investigation is currently ongoing to determine the root cause.One 3 fr single lumen powerpicc provena was returned for evaluation.An initial visual observation showed use residue throughout the returned sample.The luer connector hub was observed to be detached and missing.The sample was flushed and pressurized with a 12 ml syringe of water and was found to be patent to infusion and aspiration.A microscopic observation revealed the break surface of was rough and exhibited cracks/fissures and beach marks, which are indicative of material fatigue; however the root cause of the break is unknown at this time and an internal investigation is currently ongoing to determine the root cause.A lot history review (lhr) of rebw1843 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number rebw1843 have been reported from the same facility.
Event or Problem Description
It was reported by the facility that they found a leak due to a crack near the hub.No injury to the patient was 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: 7362050
• Report Number: 3006260740-2018-00497
• Device Sequence Number: 16152303
• 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: Other,Notification
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1