MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135 CM GUIDEWIRE); PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3276135
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2016
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
Facility contact reported that upon opening the package, the nurse observed that the guidewire was bent at the flexible end.The powerpicc was still inserted but using a new guidewire.On 10/06/2016 - returned wire has blood residue and contains a kink per engineer's evaluation.On 10/25/2016 - the facility confirmed that the guidewire was not inserted in the patient.They believe the blood residue found on the wire is from blood on the gloves of the nurse.
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.Returned sample was found with blood residue.The facility confirmed that the sample was not inserted in the patient.They believe the blood residue found on the wire is from blood on the gloves of the nurse.The information provided does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.Therefore this event is deemed not reportable per 21 cfr part 803.

• Brand Name: POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135 CM GUIDEWIRE)
• 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: 6056108
• Report Number: 3006260740-2016-00568
• Device Sequence Number: 13681081
• Product Code: LJS
• UDI-Device Identifier: 00801741028007
• UDI-Public: (01)00801741028007
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2016

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 Catalogue Number: 3276135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1