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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL
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BARD ACCESS SYSTEMS NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL Back to Search Results
Catalog Number NNU8LPT
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Of the four reported malfunctions, two lot numbers were provided and a lot history review will be performed.For one malfunction, the investigation of the reported event is inconclusive as the sample was not returned and no images or medical records were provided.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.One malfunction provided an electronic photo, another provided a video.The company is still investigating this issue.
 
Event Description
This report summarizes four malfunction.The information reviewed indicated that model nnu8lpt drainage catheter allegedly experienced a crack.This information was received from various sources.All four of the reported malfunctions involved patients with no reported consequences.One (b)(6) year old patient's weight and gender were not provided.Age, weight, and gender were not provided for the other patients.
 
Manufacturer Narrative
H10: of the four reported malfunctions, two lot numbers were provided and a lot history review will be performed.For one malfunction, the investigation of the reported event is inconclusive as the sample was not returned and no images or medical records were provided.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.One malfunction provided an electronic photo, another provided a video.The company is still investigating this issue.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.
 
Event Description
This report summarizes four malfunctions.The information reviewed indicated that model nnu8lpt drainage catheter allegedly experienced a crack.This information was received from various sources.All four of the reported malfunctions involved patients with no reported consequences.One 70 year old patient's weight and gender were not provided.Another patient was male.Age, weight, and gender were not provided for the other patients.
 
Manufacturer Narrative
H10: out of the four reported malfunctions, two lot numbers were provided and a lot history review was performed.The samples were not returned to the manufacturer for inspection/evaluation; however for two malfunctions a photo and a video has been provided and reviewed.For the one of the malfunctions, break and leak was confirmed.For the other malfunction, crack was confirmed.The remaining 2 malfunctions are inconclusive as no objective evidence was provided for review.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.H10: g4 h11: g1, h6(result, conclusion) 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.
 
Event Description
This report summarizes four malfunctions.The information reviewed indicated that model nnu8lpt drainage catheter allegedly experienced a crack.This information was received from various sources.All four of the reported malfunctions involved patients with no reported consequences.One 70 year old patient's weight and gender were not provided.Another patient was male.Age, weight, and gender were not provided for the other patients.
 
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Brand Name
NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL
Type of Device
DRAINAGE CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9593578
MDR Text Key190782359
Report Number3006260740-2020-00111
Device Sequence Number1
Product Code GBX
UDI-Device Identifier00801741037009
UDI-Public(01)00801741037009
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup
Report Date 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberNNU8LPT
Device Lot NumberGFDN4159, GFCW2179, UNKNOWN
Date Manufacturer Received06/30/2020
Patient Sequence Number1
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