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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/04/2019
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty activating safety mechanism is confirmed to be supplier related.One 22 ga x 0.75 in safestep infusion set was returned for investigation.An infusion cap was attached to the luer connector.Use residue was present throughout the device.The safety mechanism was not advanced.An attempt to activate the safety mechanism revealed resistance.Residual material was observed between the metal sleeve and needle shaft.The residue appeared to be adhesive used in the manufacturing process.The color of the material appeared to be discolored due to the use residue.The safety was able to be successfully activated with the application of additional force.Since resistance appeared to have been caused by residual adhesive used in the manufacturing process, the complaint is confirmed.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that during removal of safestep from the port body, the base did not move down and the safety mechanism didn¿t work.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)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key8846102
MDR Text Key153138632
Report Number3006260740-2019-02226
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 health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/31/2019
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2019
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 07/08/2019
Initial Date FDA Received07/31/2019
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
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