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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 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; 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 06/20/2022
Event Type  malfunction  
Event Description
It was reported that the needle was accessed to a port system on (b)(6) 2022.On (b)(6) 2022, when the patient came to the hospital after treatment at patient¿s home, it was found that needle tip could not be guarded in the base.When the safety mechanism was attempted to work, the base did not move down.There was no reported patient injury.
 
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of safety mechanism failure was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 22ga x 0.75¿ safestep safety infusion set.Light usage residues were observed throughout the sample.The safety mechanism was engaged and fully covered the needle tip.Microscopic inspection of the safety mechanism was unremarkable.Manipulation of the safety mechanism was unremarkable.The needle tip remained firmly in place over the needle tip.The safety was intentionally disengaged.Subsequent safety activation was successful and unremarkable.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.Evaluation findings are in section h.11.
 
Event Description
It was reported that the needle was accessed to a port system on (b)(6) 2022.On (b)(6) 2022, when the patient came to the hospital after treatment at patient¿s home, it was found that needle tip could not be guarded in the base.When the safety mechanism was attempted to work, the base did not move down.There was no reported patient injury.
 
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Brand Name
SAFESTEP HUBER NEEDLE SET 22G X 0.75IN
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
becky garcia
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key15177672
MDR Text Key302839231
Report Number3006260740-2022-03073
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741066160
UDI-Public(01)00801741066160
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/24/2022
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 Model NumberN/A
Device Catalogue NumberLH-0029
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/19/2022
Initial Date FDA Received08/05/2022
Supplement Dates Manufacturer Received08/24/2022
Supplement Dates FDA Received08/31/2022
Was Device Evaluated by Manufacturer? Yes
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;
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