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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAIN; CATHETER, IRRIGATION
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BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAIN; CATHETER, IRRIGATION Back to Search Results
Catalog Number NNU12LPT
Device Problems Defective Component (2292); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2018
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary:four locking pigtail 12 fr x 30cm universal drains were returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for catheter kinking for three of the four samples, as kinks were observed just distal to the proximal locking wire hole when the loop portion of the catheter was straightened for two of the three samples and the locking guide wire was with both of these samples.For the three samples kinks were also observed diametrically opposite of either the first or second drainage hole distal from the proximal end of the device.The diameters of the drainage holes diametrically opposite of kinks were measured and no abnormalities were found.The cracks on one of the samples are centered around the kink just distal to the locking wire hole.The cracks are longitudinally aligned and two of the cracks are just on either side of the kink.The arrangement of the cracks and the characteristics of the splits are consistent with characteristics resultant of puncture/tearing caused by advancing the guidewire/stylet through the catheter.The catheter breaks in two of the four samples have elliptical profiles with striations on some regions of the surface break and the break profiles are slightly inclined, which is consistent with cuts/breaks caused by tools/instruments.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues, manufacturing/supplier, and/or shipping/handling issues contributed to the reported event.Application of compressive force to the catheter and extreme temperatures may have contributed to the observed kinks.Advancing a stylet through the catheter may have contributed to the holes observed in one of the returned samples.Labeling review:a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(expiry date: 04/2020).
 
Event Description
It was reported during catheter placement, that the catheter allegedly crinkled.It was further reported that the procedure was not completed and was re-attempted at a later date.There was no reported patient injury.
 
Event Description
It was reported during catheter placement, that the catheter allegedly crinkled.It was further reported that the procedure was not completed and was re-attempted at a later date.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: one locking pigtail 12 fr x 30cm universal drains and one guidewire were returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is inconclusive for inability to advance catheter over guidewire due to catheter crinkling, as neither a metal cannula nor a plastic cannula assembly was returned.However, kinking was observed just distal to the locking wire hole when the loop was straightened.The diameter of the drainage hole diametrically opposite of the observed kink was measured; the recorded measurement was within specification.The definitive root cause could not be determined based upon available information.As cannulas were not returned with the sample, it was not possible to reproduce conditions at the time of the event (i.E.It was not possible to track the catheter with inlaid cannula over the guidewire).Therefore, it could not be determined whether the observed kink in the catheter contributed to the reported event.It is unknown if procedural issues contributed to the reported event.Labeling review:a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: d4 (expiry date: 04/2020), g4 h11: g1 h11:section a through f - the information provided by bd 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 bd.
 
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Brand Name
NAVARRE UNIVERSAL DRAIN
Type of Device
CATHETER, IRRIGATION
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8329548
MDR Text Key136142237
Report Number3006260740-2018-03904
Device Sequence Number1
Product Code GBX
UDI-Device Identifier00801741036934
UDI-Public(01)00801741036934
Combination Product (y/n)N
PMA/PMN Number
K951475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/21/2020
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 Catalogue NumberNNU12LPT
Device Lot NumberGFBQ1885
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2018
Initial Date Manufacturer Received 01/15/2019
Initial Date FDA Received02/11/2019
Supplement Dates Manufacturer Received02/20/2020
Supplement Dates FDA Received02/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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