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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 WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, 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 a missing needle guard is confirmed and was determined to be supplier related. One 20 g x 0. 75 in. Safestep infusion set with a valved y-site with what appears to be its original packaging was returned for evaluation. An initial visual observation showed no obvious evidence of use on the returned sample. No needle guard was returned with the sample and a slit was observed in the clear plastic of the returned packaging; the edges of this split were observed to flare outward on the outer side of the packaging. Under microscopic observation, the edges of the slit were observed to be mostly straight, flat, and well-defined. A non-complaint safestep package was pierced with the needle of a non-complaint safestep infusion set which was then pulled in a perpendicular direction in an attempt to recreate the slit observed in the returned packaging. The resulting damage in the non-complaint sample was compared with the damage observed on the returned packaging and was found to be very similar in shape and texture. The results of this testing suggest the needle of the alleged infusion set may have pierced its packaging from within the package, which may have been due to the lack of a guard on the needle. This device is a supplied component and the supplier has been notified of this event. A lot history review (lhr) of asdus0122 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported a nurse was opening a huber needle and the safety cover was not on the needle, resulting in the nurse poking her finger. Device was not used on a patient.
 
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Brand NameSAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE
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 Key9234442
MDR Text Key164152048
Report Number3006260740-2019-03324
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 10/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2020
Device Model NumberN/A
Device Catalogue NumberLH-0031YN
Device Lot NumberASDUS0122
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2019
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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