MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAINAGE CATHETER WITH NITINOL 12F WITH LOCKING PIGTAIL; CATHETER, IRRIGATION

Model Number N/A

Device Problems Failure to Advance (2524); Folded (2630)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2017

Event Type  malfunction  

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, at this time, for evaluation.A lot history review (lhr) of gfar2894 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.

Event Description

It was reported that one of the "holes" was folded and the inner stylet couldn't be put into the tube after the package had been opened.The product was not used on the patient.Another device was opened and used to complete the procedure.There was no reported patient injury.

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 pierced navarre drainage catheter was confirmed and the cause appeared to be use related.One 12fr navarre drainage catheter was returned for investigation.The catheter was received with the metal cannula and trocar in the lumen.The trocar had pierced the catheter where the tubing began curving at the proximal end of the pigtail.The reported complications appeared to be related to improper preparation of the device.The white hub of the trocar was attached to the white hub of the metal cannula before the metal cannula was fully inserted within the catheter.The product ifu cautions that if the trocar is to be used, ensure that hang tag between the trocar and cannula hubs remains in place during insertion.This keeps the sharp tip of the trocar within the cannula until the trocar is fully inserted into the catheter.A lot history review (lhr) of gfar2894 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that one of the "holes" was folded and the inner stylet couldn't be put into the tube after the package had been opened.The product was not used on the patient.Another device was opened and used to complete the procedure.There was no reported patient injury.

• Brand Name: NAVARRE UNIVERSAL DRAINAGE CATHETER WITH NITINOL 12F WITH LOCKING PIGTAIL
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): C.R. BARD, INC. (GFO) -1313046; 289 bay road; queensbury NY 12804
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7166337
• MDR Text Key: 96595659
• Report Number: 3006260740-2017-02376
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741036934
• UDI-Public: (01)00801741036934
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K951907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NNU12LPT
• Device Lot Number: GFAR2894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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
• Patient Age: 59 YR
• Patient Weight: 75