MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PROVENA PPICC 3FR S/L; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number UNKNOWN

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

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

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 that the hub detached from the power picc was confirmed and additional information regarding this type of complaint is contained in 3006260740-12-21-2017-001-c (z#-tbd).Two photographs were provided for investigation.One photo showed the purple connector from a power picc catheter.No portion of the extension leg was extending from the distal end of the connector.An injection cap was attached to the proximal end of the connector.The other photo showed the single-lumen power picc extending from the insertion site to the end of the extension leg.It appeared that the hub was labeled as a 3 fr device, which is indicative of a power picc provena.The connector was not attached to the extension leg.A transparent dressing, statlock, and guardiva were used with the picc.The detail of the adjoining ends of the extension leg and connector were not visible in the photograph.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

The facility reported two incidents where the hub pulled off the tubing of the provena power picc line.This report address the second device.

• Brand Name: PROVENA PPICC 3FR S/L
• 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: 7450686
• MDR Text Key: 106340352
• Report Number: 3006260740-2018-00795
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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