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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 06/25/2019
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 difficulty activating the safety mechanism was confirmed and the cause was determined to be use related. The product returned for evaluation was a one 22ga x 0. 75" safestep safety infusion set. The returned product sample was evaluated and the needle was observed to be bent near the exit site from the safety mechanism. The following observations were noted during the sample evaluation: usage residue was seen on the sample which proved that the product had experienced at least some use. The needle tip was barbed suggesting contact between the needle and port base. Force applied at an angle to the needle axis, or if the needle is not inserted perpendicular into the port septum, can lead to bending of the needle shaft. It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion. Additionally, avoid excessive manipulation once the needle is in the port. No potential damage related to the manufacturing process was noted on the complaint sample. A lot history review (lhr) of asdps0109 showed two other similar product complaint(s) from this lot number. The complaints for this lot number (asdps0109) have been reported from the same facility in (b)(4).
 
Event Description
It was reported that the safety mechanism that ensures needle is protected on removal was not working properly and therefore risk for needlestick injury. There was no impact to the patient. When the rn attempted to pull the needle out of the patient and into the locking device, it was faulty, so part of the needle was still extended beyond the ¿bottom¿ of the device. The rn did not injure herself.
 
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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 Key8804342
MDR Text Key151583311
Report Number3006260740-2019-02044
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 07/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberLH-0029
Device Lot NumberASDPS0109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2019
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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