MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV SP 4F DL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S1274108PD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rebt0146 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (rebt0146) have been reported from two u.S.Facilities.(b)(4).
Event or Problem Description
Per medwatch: "found out about this on (b)(6) 2018 from the picc team.Defect or failure created an unsafe condition." patient was brought back to facility by parents on (b)(6) 2017 with a hole in the picc line in the leg extension above the hub for the needleless connector.Patient had to go to surgery to have a broviac placed.

• Brand Name: DOT PROV SP 4F DL 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: 7585011
• Report Number: 3006260740-2018-01319
• Device Sequence Number: 18903078
• Product Code: LJS
• UDI-Device Identifier: 00801741134166
• UDI-Public: (01)00801741134166
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Recall
• Type of Report: Initial
• Report Date (Section B): 06/08/2018
• Report Date (Section F): 01/29/2018

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: S1274108PD
• Device Lot Number: REBT0146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 MO
• Date Report Sent to FDA: 01/29/2018