MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY AND SHERLOCK 3CG TIP POSIT; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number S1395108D

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2017

Event Type  malfunction  

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 rebu2321 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the sales rep that the facility reported the catheter had a tear at the 10 cm mark that was inside the patient.On (b)(6) 2017 it was reported by the facility that the tear was subcutaneous, it was not functioning so it was pulled back to make it a midline.The tear was observed when the catheter was flushed and had saline coming from the tear.

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 leak is confirmed and was determined to be use related.One 5 fr triple lumen powerpicc provena solo was returned for evaluation.An initial visual observation showed use residue on the returned sample.A large longitudinal split was observed in the catheter near the 9 cm depth marker.All three lumens of the catheter were flushed with a 12 ml syringe of water and all lumens were found to be patent to infusion and aspiration; however, a spraying leak was observed emanating from the observed split in the red lumen during infusion.A microscopic observation revealed the split had well defined edges and the fracture surface was observed to be smooth and granular in texture, which is typical of burst failures in polyurethane caused by over-pressurization.The product ifu states: ¿do not use a syringe smaller than 10 ml to flush and confirm patency.Patency should be assessed with a 10 ml syringe or larger with preservative-free 0.9% sodium chloride (sterile saline).Upon confirmation of patency, administration of medication should be given in a syringe appropriately sized for the dose.Do not infuse against resistance.¿ a lot history review (lhr) of rebu2321 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the sales rep that the facility reported the catheter had a tear at the 10 cm mark that was inside the patient.10/31/20 it was reported by the facility that the tear was subcutaneous, it was not functioning so it was pulled back to make it a midline.The tear was observed when the catheter was flushed and had saline coming from the tear.

• Brand Name: POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY AND SHERLOCK 3CG TIP POSIT
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 7039766
• MDR Text Key: 93001322
• Report Number: 3006260740-2017-02058
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741112751
• UDI-Public: (01)00801741112751
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S1395108D
• Device Catalogue Number: S1395108D
• Device Lot Number: REBU2321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1