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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 Adverse Event Without Identified Device or Use Problem (2993); Activation Problem (4042)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 12/15/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of asdss0188 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that resistance was experienced when needle removal handled by nurse, then remove the needle by hold the safety plate and which caused the needle stab to the nurse's left hand.The safety mechanism did not activate.After the needle stab issue, the safety mechanism was activated by unit head nurse.
 
Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 supplier related.The product returned for evaluation was one 20ga x 1" safestep safety infusion set.The investigation findings were consistent with misplaced or excess manufacturing adhesive, which bound the safety mechanism to the needle.The following observations were made during the sample evaluation: the sample was received with the safety mechanism engaged; however, microscopic inspection of the needle exit site from the housing revealed excess material.The material fluoresced under ultraviolet light and appeared consistent with the adhesive used to construct the device.The needle shaft and safety mechanism were both examined and were determined to be undamaged and thus were not suspected to have contributed towards the event microscopic examination under uv light assistance revealed a white/clear adhesive-like substance at the interface of the needle shaft and safety mechanism.That material fluoresced under ultraviolet light, which was consistent with the adhesive used to assemble the infusion set.From this, it appeared that adhesive was deposited on the needle shaft during device manufacture.The device is a supplied component and the supplier was notified of the event.The implicated device was manufactured prior to implementation of all corrective actions.A lot history review (lhr) of asdss0188 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that resistance was experienced when needle removal handled by nurse, then remove the needle by hold the safety plate and which caused the needle stab to the nurse's left hand.The safety mechanism did not activate.After the needle stab issue, the safety mechanism was activated by unit head nurse.
 
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Brand Name
SAFESTEP HUBER NEEDLE SET 20G X 1 IN
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9572105
MDR Text Key183563931
Report Number3006260740-2019-04122
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741066221
UDI-Public(01)00801741066221
Combination Product (y/n)N
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberLH-0032
Device Lot NumberASDSS0188
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2020
Event Location Hospital
Date Manufacturer Received02/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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