MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5 FR. D/L POLY RADPICC WITH 135 CM GUIDEWIRE KIT; IMPLANTED, LONG TERM INTRAVASCULAR CATHETERS

Model Number	3265135
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reat1367 showed no other similar product complaint(s) from this lot number.Device not yet returned.
Event or Problem Description
It was reported that the doctor could not remove the guidewire from the catheter because it was kinked inside catheter.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.The returned sample shows evidence of mild bends but no kinks (permanent deformation of the wire coils).This event does not pose an incremental risk of harm to the patient, use or other person.There was no allegation of an injury or death associated with this event.Therefore, this event is deemed not reportable per cfr 21 par 803.19.
Event or Problem Description
It was reported that the doctor could not remove the guidewire from the catheter because it was kinked inside catheter.

• Brand Name: 5 FR. D/L POLY RADPICC WITH 135 CM GUIDEWIRE KIT
• Common Device Name: IMPLANTED, LONG TERM INTRAVASCULAR CATHETERS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6817251
• Report Number: 3006260740-2017-01427
• Device Sequence Number: 852400
• Product Code: LJS
• UDI-Device Identifier: 00801741035104
• UDI-Public: (01)00801741035104
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K031129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: 05/28/2019
• Device Model Number: 3265135
• Device Catalogue Number: 3265135
• Device Lot Number: REAT1367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR