MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F NURSE BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3295118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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, trend 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: a fibrin sheath was found on the external surface of the complaint sample that was investigated under complaint record # (b)(4).One 5 fr d/l powerpicc solo was returned for investigation.A visual observation of the catheter revealed that the extension legs (tubing between the solo hub and the bifurcation) were slightly cloudy when compared to an unused sample, which is typical of use, but the tubing was still translucent and nothing was noted within the extension legs.A functional test of the powerpicc revealed that the lumens were occluded.The syringe plunger was held down to create a positive pressure within the powerpicc, which caused residue to be expelled from each lumen.The residue may have consisted of blood and other infusates that were left in the picc.Tape residue was visible on the extension legs and the solo hubs.The printing on the extension legs was worn from the tubing.The printing on the bifurcation was partially worn.Residue, which may have been from the adhesive dressing, remained adhered to the d/l tubing between the bifurcation and 2cm depth mark.A red colored residue was visible on the d/l tubing between the 12 and 27 cm depth marks.What appear to be remnants of a fibrin sheath are visible between the 13 and 15 cm depth marks.The product ifu lists fibrin sheath formation as a potential complication.A lot history review (lhr) of rezc0704 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016 - bas engineers found that the sample returned for a separate complaint had a fibrin sheath on the subcutaneous section of the catheter.

• Brand Name: POWERPICC SOLO CATHETER 5F NURSE BASIC TRAY (DUAL-LUMEN) (WITH MICROINTRODUCER)
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5510427
• Report Number: 3006260740-2016-00112
• Device Sequence Number: 16434654
• Product Code: LJS
• UDI-Device Identifier: 00801741028090
• UDI-Public: (01)00801741028090(17)160828(10)REZC0704
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2016
• Device Catalogue Number: 3295118
• Device Lot Number: REZC0704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1