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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 Problems Misassembled (1398); Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2019
Event Type  malfunction  
Manufacturer Narrative
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 detachment was confirmed and the cause was supplier related. The product returned for evaluation was one 22ga safestep safety plate. The safety plate was received fully detached from the infusion set needle. The infusion set was not returned for evaluation. The safety plate was disassembled and the metal sleeve inner diameter was measured using a digital microscope. The inner diameter was found to be outside of manufacturing specifications. It appeared that the incorrect metal sleeve used during device assembly. This is a supplied component and the supplier has been notified of this event. 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 when removing the safestep from the port body, the base could not secure the needle tip and slipped off from the needle. There was no reported patient injury.
 
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Brand NameSAFESTEP HUBER NEEDLE SET 22G X 0.75IN
Type of DeviceSET, 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 Key9035881
MDR Text Key158198667
Report Number3006260740-2019-02684
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 09/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberLH-0029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/20/2019
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

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