MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE PERCUTANEOUS BILIARY DRAINAGE CATHETER WITH NITINOL, 12F LOCKING PIGTAIL; PATIENT CARE SUCTION APPARATUS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of gfax1447 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that while preparing for the ptc procedure, the nurse threaded the plastic stylet over the catheter.They reportedly found that the catheter had kinked while straightening.It was stated that the decision was made not to use the catheter and a new set was opened to complete the procedure.Device was not used on a patient.
Additional Manufacturer Narrative
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 catheter was kinking when it was straightened was confirmed, but the exact cause was unknown.One 12fr navarre drainage catheter was returned for investigation.The coiled portion of the catheter kinked along the outside of the curve when the catheter was straightened.The catheter was cut at the proximal end of the curl which revealed variation in the thickness of the coating from the dip process.A review at the manufacturing facility found that the sample was manufactured to specification.A review of the manufacturing records found nothing to indicate there was a manufacturing related cause for this event.A lot history review (lhr) of gfax1447 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that while preparing for the ptc procedure, the nurse threaded the plastic stylet over the catheter.They reportedly found that the catheter had kinked while straightening.It was stated that the decision was made not to use the catheter and a new set was opened to complete the procedure.Device was not used on a patient.

• Brand Name: NAVARRE PERCUTANEOUS BILIARY DRAINAGE CATHETER WITH NITINOL, 12F LOCKING PIGTAIL
• Common Device Name: PATIENT CARE SUCTION APPARATUS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7033255
• Report Number: 3006260740-2017-02028
• Device Sequence Number: 19185150
• Product Code: FGE
• UDI-Device Identifier: 00801741036859
• UDI-Public: (01)00801741036859
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K955110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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: 10/01/2019
• Device Model Number: N/A
• Device Catalogue Number: NBD12
• Device Lot Number: GFAX1447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1