MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Material Deformation (2976)

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, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of a loose connection and leak at the proximal luer adaptor was confirmed and the cause appears to be associated with use.The product returned for evaluation was a 20g x 1¿ safestep infusion set with y-injection site.The investigation findings are consistent with damage accumulated through gradual deformation due to continuous outward-radiating stress within the luer hub orifice, also known as material creep.Likely sources of the stress include slip-fit style male luer adapters such as those found on some i.V.Administration sets and syringes.The returned product sample was evaluated and the characteristics observed which supported this type of failure included: ¿ the luer hub orifice was found to be out of iso tolerance using a calibrated taper gauge ¿ usage residue was seen throughout the sample ¿ lack of mechanical damage on the luer hub ¿ leakage from the luer hub was confirmed during infusion testing with a luer lock syringe ¿ attachment of the device to non-complainant slip-fit adapters showed that the tapers could be fully inserted into the luer hub orifice the evidence suggests that a tapered object was forcefully inserted into the luer hub orifice then left in place, resulting in gradual widening, or creep, of the luer hub material.This type of failure was replicated at vad using 5 iso compliant slip-fit adapters and 5 non-complainant infusion sets.A combination of use of slip-fit style adapters, the force with which those adapters were inserted, and the duration of insertion resulted in this type of slow luer hub deformation.Creep deformation takes place over days; however, the rate of deformation depends upon the force used to insert the taper.This type of damage may possibly be mitigated by reducing the insertion force and/or using luer-lock style adapters.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 there was a leak at connection between syringe and luer adaptor.No other information was provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 1 IN WITH Y-SITE
• Type of Device: SET, 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 Key: 9990590
• MDR Text Key: 200042157
• Report Number: 3006260740-2020-01498
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066238
• UDI-Public: (01)00801741066238
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0032YN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1