MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 10F LOCKING PIGTAIL; STAND, INFUSION

Catalog Number NOD10LPT

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date (b)(6) 2020.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.

Event Description

It was reported that the drain was placed under ct.The day after placement the device was flushed as prescribed.When attempting to flush, allegedly it was noticed that the piece that connects the catheter to the drainage bag was split.The device was removed and replaced.There was no reported patient injury.

• Brand Name: NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETER 10F LOCKING PIGTAIL
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8084321
• MDR Text Key: 127564715
• Report Number: 3006260740-2018-03270
• Device Sequence Number: 1
• Product Code: FOX
• UDI-Device Identifier: 00801741037030
• UDI-Public: (01)00801741037030
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NOD10LPT
• Device Lot Number: GFBZ0771
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1