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 Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of recx0924 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the line is detached from the end of the wing.No other information was provided.
Event or Problem Description
It was reported the line is detached from the end of the wing.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a extension leg break is confirmed but the exact cause remains unknown.One 22 ga x 0.75in winged infusion set was returned for investigation.Dried use residue was present within the extension tubing and proximal luer hub.The y-site hub was found to be detached from the y site extension tubing and was not returned.Microscopic observation of the extension leg break surface revealed it to be uneven and granular.The break surface characteristics suggest that kinking, tensile, and torsional stress may have contributed to the extension leg break.Since a complete break was observed on the extension tubing, the complaint is confirmed.A lot history review (lhr) of recx0924 showed no other similar product complaint(s) from this lot number.

• 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: 9199884
• Report Number: 3006260740-2019-03069
• Device Sequence Number: 13565174
• 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,Followup
• Report Date (Section B): 11/27/2019

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: RECX0924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1