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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.5IN; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.5IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2023
Event Type  malfunction  
Event Description
It was reported by the customer ¿patient used the needle, it worked ok but she was unable to activate the safety mechanism when she removed it from her chest.¿ additional information received (b)(6)2023: it was reported by the customer ¿event did not involve an urgent or life threatening medical situation, did not cause patient harm, injury, complication or negative outcome.No interruption in treatment.¿.
 
Manufacturer Narrative
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.The manufacturer has received the sample and is pending evaluation.Results are expected soon.
 
Manufacturer Narrative
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.The complaint of inability to activate the safety mechanism on an infusion set is inconclusive due to the state of the returned samples.Two sealed 20 ga x 0.5 in safestep safety infusion sets were returned for evaluation.An initial visual observation showed both returned infusion sets to be batch samples from the same batch.Each infusion set appeared unremarkable upon initial visual observations.A functional test of attempting to activate the safety of each infusion set were unremarkable, and both samples 1 and 2 performed as intended.A microscopic observation revealed nothing remarkable on either returned lot sample.The complaint of a safety mechanism having difficulty activating is inconclusive because the returned products were lot samples.
 
Event Description
It was reported by the customer ¿patient used the needle, it worked ok but she was unable to activate the safety mechanism when she removed it from her chest.¿ additional information received 7-july-2023: it was reported by the customer ¿event did not involve an urgent or life threatening medical situation, did not cause patient harm, injury, complication or negative outcome.No interruption in treatment.¿.
 
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Brand Name
SAFESTEP HUBER NEEDLE SET 20G X 0.5IN
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer Contact
kayla bevins
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key17358223
MDR Text Key319372384
Report Number3006260740-2023-03062
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741066320
UDI-Public(01)00801741066320
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberLH-0037
Device Lot NumberASGTFC025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age43 YR
Patient SexFemale
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