MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV 3F SL MAX TLS; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	S9173108D
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/29/2017
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, as the device remains in the patient.A lot history review (lhr) of rebq2475 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility, via the sales rep, that they used a 3 fr provena catheter on (b)(6) 2017, the nurse stated that she did not believe that the catheter had enough "body" to it to easily drop into the svc.She stated she struggled for nearly twenty minutes to drop what should have been a very easy picc on a (b)(6).She stated the sherlock went "wild" turning up and down and then up and down again, finally resting with the "popsicle" up and looking like the catheter was coming from mid chest.After getting an x-ray, she found that she had cannulated the azygous vein, which she stated is not very easy to do.

• Brand Name: DOT PROV 3F SL MAX TLS
• 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: 6803817
• Report Number: 3006260740-2017-01359
• Device Sequence Number: 11202543
• Product Code: LJS
• UDI-Device Identifier: 00801741130427
• UDI-Public: (01)00801741130427
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

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: S9173108D
• Device Lot Number: REBQ2475
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR