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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 11/15/2023
Event Type  malfunction  
Event Description
It was reported that when removing the needle, everything that fit into the case did not fit and the needle tip was sticking out.There was no reported patient injury.No other information was provided.
 
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 difficulty advancing the safety mechanism is confirmed, but the root cause could not be determined.One 22 ga x 0.75 in.Safestep infusion set was returned for evaluation.An initial visual observation revealed use residues throughout the returned safestep infusion set.The safety mechanism was not engaged upon the return of the device.A functional test of attempting to engage the safety mechanism revealed difficulties advancing the needle safety.The needle safety mechanism advanced with some difficulty.A microscopic observation revealed a bend towards the proximal end of the safety mechanism after the safety was engaged.Because it could not be determined whether the bend in the needle occurred during use or before use, the complaint of difficulty engaging the safety mechanism is confirmed, but the root cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported that when removing the needle, everything that fit into the case did not fit and the needle tip was sticking out.There was no reported patient injury.No other information was provided.
 
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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
maddy vincent
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key18271619
MDR Text Key329807888
Report Number3006260740-2023-05514
Device Sequence Number1
Product Code FPA
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 User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/19/2024
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 NumberASGWFC038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/21/2023
Initial Date FDA Received12/05/2023
Supplement Dates Manufacturer Received03/19/2024
Supplement Dates FDA Received03/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2022
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;
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