MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 2194108

Device Problems Infusion or Flow Problem (2964); Appropriate Term/Code Not Available (3191)

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

Event Date 09/06/2018

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 device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of recs3009 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the valve on the picc was not working and blood was back flowing in the catheter.The picc remained implanted to the patient (closed with an additional valve).

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 bleed back was inconclusive due to the sample condition and because clinical conditions could not be replicated.One 4fr s/l powerpicc solo was returned for investigation.The catheter exhibited evidence of use.The catheter had been cut at the 37 cm depth mark and the distal segment of the catheter was not returned for investigation.The printing on the extension leg was worn.The printing on the molding wing and the 0-2 cm depth marks was partially worn.A non-vad needleless injection cap was attached to the luer adaptor.The solo valve was in its proper position.A microscopic examination revealed residue from use within the solo valve, which may have affected the functional performance of the valve.A functional test revealed that the catheter was patent to infusion and no leaks were observed in any part of the catheter.One of the benefits of the proximal (solo) valve is reduced blood reflux compared to open-ended catheters.The product ifu provides instructions for flushing and maintaining the catheter to keep the valve clean.Injection caps or end caps should be attached to the catheter hub and securely tightened.Injection caps should be changed every seven days or per agency policy, when the injection cap has been removed for any reason, or anytime the cap appears damaged, is leaking, or blood is seen in the catheter without explanation or blood residue is observed in the injection cap.

Event Description

It was reported that the valve on the picc was not working and blood was back flowing in the catheter.The picc remained implanted to the patient (closed with an additional valve).

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F
• Type of Device: 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: 7936750
• MDR Text Key: 122814244
• Report Number: 3006260740-2018-02725
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741138973
• UDI-Public: (01)00801741138973
• Combination Product (y/n): N
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2194108
• Device Lot Number: RECS3009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Event Location: Hospital
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1