MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 1295108D

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

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

Event Date 08/19/2015

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, at this time, for evaluation.A lot history review (lhr) of reyi1078 showed no other similar product complaint(s) from these lot numbers.

Event Description

On (b)(6) 2015 - the facility and the patient stated it was leaking around the bulb area for the last week.It reportedly leaks when no fluids are infusing.Complainant dc'd the picc (b)(6) 2015, and at that time the biopatch was allegedly saturated with serous fluid and moisture was reportedly under the tegaderm.No visible fluid seen around bulb(valve) of either port.Facility stated that dressing has been completely dry each day that the fluid has been present.Picc was dc'd without complications.When pressing around the site, supposedly a small amount of clear fluid came out from the site.

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 complaint of a leaking catheter was unconfirmed because the problem could not be replicated.The product returned for evaluation was one 5fr d/l powerpicc solo catheter.Usage residues were evident throughout the sample.The catheter terminated at the 36cm depth marking.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion and aspiration with no observed leaks.No leaks were observed during hydraulic pressurization of the sample.Microscopic inspection of the sample did not reveal any damage or manufacturing defects.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG
• 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: christy chandonia ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225631
• MDR Report Key: 5072470
• MDR Text Key: 26030171
• Report Number: 3006260740-2015-00407
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Report Date: 08/24/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 1295108D
• Device Lot Number: REYI1078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• 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
• Patient Outcome(s): Required Intervention