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

Catalog Number	S9274108D
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebu0691 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebu0691) have been reported from two facilities.Device has not been returned, at this time.
Event or Problem Description
The facility reported that the patient's line was placed on (b)(6) 2018.It was stated that the purple port completely slid off the line.
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 catheter leak was confirmed and the failure is being further investigated under 3006260740-12-21-2017-001-c (z#-tbd).The product returned for evaluation was a 4fr d/l powerpicc provena catheter.The sampled contained white/gray dressing residue on the extension legs and molded joint.The purple luer hub had broken from the extension leg.Microscopic examination of the fracture surface showed that it was rough and granular and contained striation-like lines which are typical of fatigue based failures.Examination of the red luer hub, which remained attached to the opposite extension leg, found tearing of that extension leg.The tearing correlated to points where the extension tubing adhered to the luer hub.Tearing was not observed on regions of the extension tubing which were not adhered to the extension leg.The fracture features at the damage site appeared similar to fatigue damage and flexural fatigue may have been a contributing factor but the damage location and tacking of the extension tube to the luer wall suggest other, unknown, contributing factor(s) may have also been involved which will be further investigated under 3006260740-12-21-2017-001-c (z#-tbd).A lot history review (lhr) of rebu0691 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebu0691) have been reported from two facilities.
Event or Problem Description
The facility reported that the patient's line was placed on (b)(6) 2018.It was stated that the purple port completely slid off the line.

• Brand Name: DOT PROV 4F DL MAX TLS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7350178
• Report Number: 3006260740-2018-00459
• Device Sequence Number: 952437
• Product Code: LJS
• UDI-Device Identifier: 00801741130441
• UDI-Public: (01)00801741130441
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall,Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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: S9274108D
• Device Lot Number: REBU0691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1