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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 LH-0031
Device Problems Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2018
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the adaptor could not be connected with infusion set & syringe firmly and caused the drug leak.It was stated this happened with four devices.This report addresses the third device.
 
Event Description
It was reported that the adaptor could not be connected with infusion set & syringe firmly and caused the drug leak.It was stated this happened with four devices.This report addresses the third device.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: it is possible that the reported leaking occurred at the tubing connection site due to deformation in the luer adaptor and the damage to the luer adaptor most likely occurred during use.One 20 g safestep infusion set was returned for evaluation.The infusion set was received with a 3-way stop-cock attached to the luer adaptor.Use residue was observed between the luer threads and the syringe/stop-cock.Functional testing revealed that the safestep infusion set was patent to infusion.When the infusion set was pressurized with water from a slip fit syringe and a luer lock syringe, no leaks were detected at the connection between the syringes and the female luer adaptor.Inspection of the luer adaptor using an iso taper gage revealed that the hub had plastically deformed, which may have contributed to the alleged leak.Gradual deformation of the luer adaptor can occur over time with continual over-tightening.Even though the taper gage indicated the luer adaptor had deformed, functional testing in the lab revealed that the connection between the luer hub and the syringes was firm and created a seal that did not leak.Microscopic inspection of the luer hub did not reveal any thread damage, stress cracking, or material discoloration.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
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Brand Name
SAFESTEP HUBER NEEDLE SET 20G X 0.75IN
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key7939559
MDR Text Key123200717
Report Number3006260740-2018-02758
Device Sequence Number0
Product Code FPA
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 11/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLH-0031
Device Catalogue NumberLH-0031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2018
Event Location Hospital
Initial Date Manufacturer Received 09/11/2018
Initial Date FDA Received10/05/2018
Supplement Dates Manufacturer Received10/17/2018
Supplement Dates FDA Received11/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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