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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 12 FRENCH NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL
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BARD ACCESS SYSTEMS 12 FRENCH NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL Back to Search Results
Catalog Number NNU12LPT
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided and a lot history review was performed.The sample was not returned for evaluation; however, a photo was provided for review.The catalog number identified has not been cleared in the us, but is similar to the universal drainage catheters with nitinol products that are cleared in the us.The pro code for the universal drainage catheters with nitinol products is identified.The investigation is still underway.The device was labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model nnu12lpt drainage catheter allegedly experienced a connector crack.This information was received from one source.This malfunction did involve a patient with no reported patient injury.The patient was a (b)(6) year old male that weighed (b)(6) kgs.
 
Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The catalog number identified in section d4 has not been cleared in the us, but is similar to the universal drainage catheters with nitinol products that are cleared in the us.The pro code for the universal drainage catheters with nitinol products is identified in d2.The sample was not returned for evaluation; however, a photo was provided for review.The investigation is inconclusive for the alleged issue.Based on the available information definitive root cause could not be determined.The device was labeled for single use.H10: g4.H11: g1, h6, (method, results & 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 one malfunction.A review of the reported information indicated that model nnu12lpt drainage catheter allegedly experienced a connector crack.This information was received from one source.This malfunction did involve a patient with no reported patient injury.The patient was a 70 year old male that weighed 67 kgs.
 
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Brand Name
12 FRENCH 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 Key9593811
MDR Text Key190782918
Report Number3006260740-2020-00114
Device Sequence Number1
Product Code GBX
UDI-Device Identifier00801741036934
UDI-Public(01)00801741036934
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 07/01/2020
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 NumberNNU12LPT
Device Lot NumberGFBW2297
Date Manufacturer Received06/30/2020
Patient Sequence Number1
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