MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROV 3F SL IR 70CM NI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S3173355
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebq2586 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the provena line is breaking directly below the purple hub connector.The facility stated that the patient had to return to radiology to have another line placed.
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 tear in the extension leg was confirmed.One photograph of a powerpicc extension leg was provided for investigation.A tear in the extension leg was observed at the distal end of the purple luer adaptor.Residue was observed on or within the extension leg.A non-bas injection cap was attached to the purple connector.The notes with the photograph implicated a 3fr s/l catheter.The date of incident was (b)(6) 2017 and the date of placement was (b)(6) 2017.An internal investigation has been opened to determine the root cause.A lot history review (lhr) of rebq2586 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the provena line is breaking directly below the purple hub connector.The facility stated that the patient had to return to radiology to have another line placed.
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 tear in the extension leg was confirmed.One photograph of a powerpicc extension leg was provided for investigation.A tear in the extension leg was observed at the distal end of the purple luer adaptor.Residue was observed on or within the extension leg.A non-bas injection cap was attached to the purple connector.The notes with the photograph implicated a 3fr s/l catheter.The date of incident was (b)(6) 2017 and the date of placement was (b)(6) 2017.An internal investigation has been opened to determine the root cause.A lot history review (lhr) of rebq2586 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the provena line is breaking directly below the purple hub connector.The facility stated that the patient had to return to radiology to have another line placed.

• Brand Name: PROV 3F SL IR 70CM NI
• 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: 6974837
• Report Number: 3006260740-2017-01897
• Device Sequence Number: 2037602
• Product Code: LJS
• UDI-Device Identifier: 00801741129971
• UDI-Public: (01)00801741129971
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2018

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 Expiration Date: 01/31/2018
• Device Catalogue Number: S3173355
• Device Lot Number: REBQ2586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017; 12/28/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/09/2017; 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1