MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WINGED INFUSION SET 19G X 1 IN; 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)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redr3230 showed six other similar product complaint(s) from this lot number.The complaints for this lot number (redr3230) have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported a leakage of cytostat preparations in various patients.It was stated when receiving chemo a leakage was noted with 7 patients.Some patients had to come in from home.At all 7 patients the same lot# was used.This report addresses the third patient.

• Brand Name: WINGED INFUSION SET 19G X 1 IN
• 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: 9655075
• Report Number: 3006260740-2020-00371
• Device Sequence Number: 16868317
• Product Code: FMI
• UDI-Device Identifier: 00801741037573
• UDI-Public: (01)00801741037573
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0604180
• Device Lot Number: REDR3230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization