MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION RFA, LUER LOCK - LUER LOCK; SYRINGE, PISTON

Catalog Number	H93813901
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a ¿dead bug (gnat likely)¿ was observed inside a sealed rapidfill connector.This was identified during setup and preparation.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h4: and h6:.Additional information/correction: d4: expiration date (missing from initial report).H4: lot manufactured between august 12, 2020 to august 14, 2020.H10: a batch review was conducted, and there were no deviations found related to this reported condition, during the manufacture of this lot.The device was not received for evaluation.Therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: RFA, LUER LOCK - LUER LOCK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11173029
• Report Number: 1416980-2020-08504
• Device Sequence Number: 2551689
• Product Code: FMF
• UDI-Device Identifier: 00085412478364
• UDI-Public: (01)00085412478364
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K872743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: H93813901
• Device Lot Number: 60252648
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1