MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE PERCUTANEOUS BILIARY DRAINAGE CATHETER WITH NITINOL, 10F LOCKING PIGTAIL

Model Number	NBD10
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2018
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
It was reported that the rn called the sales rep to report a cracked drainage catheter, allegedly the hub was cracked.No further details were given.
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 of a cracked connector on the returned drainage catheter was confirmed, but the root cause of the damage was unknown.One 10fr locking pigtail drainage catheter was returned for investigation.The product appeared to be used.Sutures were tied around the drainage catheter and the rubber seal had been advanced over the indent.The white connector was cracked and two 3mm x 1mm x 1mm fragments broke away from the threads and were not returned for investigation.The fractured surfaces of the white connector were jagged and uneven.While the damage reportedly occurred during use, the exact cause of the cracked material was not determined.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the rn called the sales rep to report a cracked drainage catheter, allegedly the hub was cracked.No further details were given.

• Brand Name: NAVARRE PERCUTANEOUS BILIARY DRAINAGE CATHETER WITH NITINOL, 10F LOCKING PIGTAIL
• Common Device Name: CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7304292
• Report Number: 3006260740-2018-00312
• Device Sequence Number: 1067048
• Product Code: FGE
• UDI-Device Identifier: 00801741036842
• UDI-Public: (01)00801741036842
• 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): 05/02/2018

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 Model Number: NBD10
• Device Catalogue Number: NBD10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1