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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 recv3693 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.
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 line detachment was inconclusive because the returned sample did not appear to be the originally implicated device.The product returned for evaluation was one 22ga x 0.75¿ winged infusion set.The sample was received in its original sealed package.The device was unremarkable to gross inspection.The tubing joints appeared unremarkable.Tactile inspection of the sample was unremarkable.Microscopic inspection of the sample was unremarkable.Attachment of non-complainant luer-lock accessories to both the proximal luer adapter and y-site luer adapter were successful and unremarkable.No device deficiencies were discovered during evaluation of the returned sample; however, the sealed state of the packaging suggested that the returned device may have been a lot sample, rather than the actual device implicated in the complaint.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of recv3693 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.

• 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: 9234970
• Report Number: 3006260740-2019-03331
• Device Sequence Number: 14050520
• 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): 11/22/2019

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: RECV3693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1