MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO 5F SINGLE-LUMEN CATHETER BASIC TRAY (WITH 135CM NITINOL GUIDEWIRE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 6195335

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Code Available (3191)

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 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 blood reflux in the catheter was inconclusive due to non-original product return.Eight unopened 5 fr sl powerpicc solo catheter kits were returned for investigation for complaints.The product information on all of the kits returned have ref: (b)(4) and lot: recr1909.The samples were opened and the catheters were inspected.Microscopic observation of the solo hub valves revealed no apparent issues.The samples were flushed and then aspirated using a 12 ml syringe and were found to be patent to infusion and aspiration.Since no functional issues were observed on the returned lot samples, the complaint of blood reflux is inconclusive since the devices in which the alleged complaints occurred were not returned and the clinical conditions are unknown.Based on the description of the reported events, possible contributing factors include valve damage and maintenance technique.One of the benefits of the proximal (solo) valve is to reduce 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.A lot history review (lhr) of recr1909 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (recr1909) have been reported from the same facility in (b)(4).

Event Description

It was reported that there was blood backflow to valve of the picc, despite rinsing and appropriate handling.The picc is still implanted as the hcp does not want to exchange.Additional information received stated, "in (b)(6) detection of blood backflow in the catheter out to the outside with obstruction of the catheter.All three catheters were resuscitated so that only additional treatment and control occurred".This report addresses the third of three catheters.

• Brand Name: POWERPICC SOLO 5F SINGLE-LUMEN CATHETER BASIC TRAY (WITH 135CM NITINOL GUIDEWIRE
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7936804
• MDR Text Key: 122804734
• Report Number: 3006260740-2018-02739
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741139697
• UDI-Public: (01)00801741139697
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2018

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: 6195335
• Device Lot Number: RECR1909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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