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

Catalog Number	S3173108D
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 leakage is inconclusive, due to poor sample condition.Two photographs of what appeared to be a powerpicc and a product information sticker were returned for evaluation.An initial visual observation of the first photograph showed a plastic bag with a specimen jar containing what appears to be a powerpicc.There appears to be blood residue on the powerpicc.Due to the position of the sample in the photograph as well as the overall quality of the photograph, it was not possible to observe any damage on the catheter.A lot history review (lhr) of rebt1882 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the sales rep that two provena catheters leaked infusate and blood from the extension leg.It was stated that there was no harm to the patient.This file addresses the second of the two devices.

• Brand Name: DOT PROV 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: 7383667
• Report Number: 3006260740-2018-00548
• Device Sequence Number: 19106260
• Product Code: LJS
• UDI-Device Identifier: 00801741130380
• UDI-Public: (01)00801741130380
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,user f
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Notification
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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: S3173108D
• Device Lot Number: REBT1882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1