MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 19G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional 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 a leaking infusion set was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 19ga x 1.5¿ safestep safety infusion set.Usage residues were observed throughout the sample.The safety mechanism was engaged and a needleless injection cap was attached to the luer.A partially circumferential split was observed just distal of the adhesive filet, at the luer adapter/extension tubing joint.Microscopic inspection of the split revealed a granular fracture surface.Straight parallel beach marks were observed in the fracture surface.Material buckling was observed in the vicinity of the split.The fracture features were consistent with damage accumulated through material fatigue, wherein the device is subject to repetitive kinking and/or twisting stress which leads to material failure.The location of the damage suggested that device maintenance and access techniques may have contributed.A lot history review (lhr) of ascys0105 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the huber needle was leaking due to break in tubing.It was stated the break did not occur until 2-3 days after insertion.No patient harm reported.

• Brand Name: SAFESTEP HUBER NEEDLE SET 19G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8692459
• Report Number: 3006260740-2019-01621
• Device Sequence Number: 1968602
• Product Code: FPA
• UDI-Device Identifier: 00801741066269
• UDI-Public: (01)00801741066269
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0034
• Device Lot Number: ASCYS0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1