MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET WITH INJECTION SITE 22G X 0.75IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a split in the extension tubing is confirmed but the exact cause remains unknown.Two opened and one sealed 22 ga x 0.75 winged infusion set packages were returned for investigation; however, four 20 ga x 0.75 in wing infusion set devices were also returned.Two of the packaging labels contained lot: recx2098 with one of them being sealed.The third packaging label contained lot: recr2915.One sample was returned with evidence of use within the extension tubing.The used sample contained adhesive tape on the wings.A split was observed in the extension tubing distal to the proximal hub.The three unused samples were flushed with water using a 12 ml syringe and no leaks were observed during infusion and pressurization.Microscopic observation of the damaged sample with a split in the extension leg revealed a rough and uneven surface.Based on the condition of the returned sample, possible contributing factors include securement technique, material fatigue, and excessive tensile force.A lot history review (lhr) of recr2915 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recr2915) have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported "the needle extension was cut from the luer lock side".

• Brand Name: WINGED INFUSION SET WITH INJECTION SITE 22G X 0.75IN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9188761
• Report Number: 3006260740-2019-03025
• Device Sequence Number: 2311195
• Product Code: FMI
• UDI-Device Identifier: 00801741065873
• UDI-Public: (01)00801741065873
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

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: 2205222
• Device Lot Number: RECR2915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1