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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 0.75IN SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problems Material Deformation (2976); Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/20/2019
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 the safety mechanism not covering the needle tip was confirmed; however, the root cause was not identified. The product returned for evaluation was one photograph depicting a 20ga x 0. 75¿ safestep safety infusion set. Usage residues were observed throughout the depicted device. A syringe was attached to the luer adapter. An injection cap was placed over the needle tip. The safety mechanism was advanced partially along the needle shaft but did not cover the needle tip. While it was apparent in the photograph that the safety mechanism was not covering the needle tip, inspection of the photograph was insufficient to determine the cause of the failure. Consequently this complaint is confirmed as ¿cause unknown¿ at this time. Potential contributing factors include safety mechanism damage and a bend in the needle shaft. A lot history review (lhr) of asdss0091 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that there was resistance felt during removal and the needle could not be retracted. No other information was provided.
 
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Brand NameSAFESTEP HUBER NEEDLE SET 20G 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
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key9596529
MDR Text Key190995259
Report Number3006260740-2020-00126
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberLH-0031
Device Lot NumberASDSS0091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received02/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2020
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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