MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAINAGE CATHETER WITH NITINOL 6F PIGTAIL; PATIENT CARE SUCTION APPARATUS

Model Number N/A

Device Problems Folded (2630); Device Operates Differently Than Expected (2913)

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

Event Date 06/11/2017

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 manufacturer has received the sample and will evaluate.Results are expected soon.Aa lot history review (lhr) of gfan1657 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (gfan1657) have been reported from the same (b)(4) facility.

Event Description

It was reported that the pigtail was folded and couldn't drain successfully.No patient injury was reported.

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 poor drainage was confirmed due to kinks that were observed in the catheter, which appear to have developed during use.One 6fr locking pigtail drainage catheter was returned for investigation.A 2cm section of residue was observed on the catheter 10cm from the distal end of the rubber seal, which confirms that the catheter was used.A kink was observed in the catheter at the proximal hole through which the string passes and at a point 2.3cm proximal to this hole.A microscopic examination revealed creases in the tubing where the catheter was kinked.A functional test confirmed that when the catheter was kinked, fluid flow through the catheter was affected.The catheter may have been placed in a location that caused the tubing to kink.

Event Description

It was reported that the pigtail was folded and couldn't drain successfully.No patient injury was reported.

• Brand Name: NAVARRE UNIVERSAL DRAINAGE CATHETER WITH NITINOL 6F PIGTAIL
• Type of Device: PATIENT CARE SUCTION APPARATUS
• 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: 6745273
• MDR Text Key: 81257691
• Report Number: 3006260740-2017-01126
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741000348
• UDI-Public: (01)00801741000348
• Combination Product (y/n): N
• PMA/PMN Number: K951475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: N/A
• Device Catalogue Number: NNU6LPT
• Device Lot Number: GFAN1657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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: 40 DA