MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

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.

• 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 Key: 7939559
• MDR Text Key: 123200717
• Report Number: 3006260740-2018-02758
• Device Sequence Number: 0
• Product Code: FPA
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• 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 Number: LH-0031
• Device Catalogue Number: LH-0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1