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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problems Nonstandard Device (1420); Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/16/2019
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; however, the root cause was not identified. The product returned for evaluation was one photograph which depicted a 20ga safestep safety infusion set. The device was contained in a plastic bag. A syringe was attached to the luer adapter. Usage residues appeared to be present within the device. The safety mechanism plate appeared to be detached from the needle. While it appeared that the safety mechanism plate was detached from the infusion set in the supplied photograph, inspection of that photograph was insufficient to identify the cause of the detachment. Consequently this complaint is confirmed as ¿cause unknown¿ at this time. Potential contributing factors include safety plate damage, needle damage and forceful advancement of the safety during needle withdrawal. A lot history review (lhr) of asdps0235 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that when trying to active safety mechanism, needle separated with hub.
 
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Brand NameSAFESTEP HUBER NEEDLE SET 20G X 1 IN
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 Key9056691
MDR Text Key158635709
Report Number3006260740-2019-02716
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberLH-0032
Device Lot NumberASDPS0177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2019
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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