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	07/02/2020
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 black particulate matter was observed in the primary packaging of a rapidfill connector.This was identified prior to use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d10, h3, h4 and h6.H4: the lot was manufactured between january 27, 2020 - january 28, 2020.H10: the actual sample was received for evaluation.Unaided visual inspection was performed which revealed a dark particulate matter on the inside of the primary packaging.Additional magnified inspection was performed which verified a dark loose particulate matter approximately 0.05 square millimeters on the product surface; which is not in the fluid pathway.The reported condition was verified.The cause of the condition is manufacturing related.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: 10338298
• Report Number: 1416980-2020-04475
• Device Sequence Number: 3749461
• Product Code: FMF
• UDI-Device Identifier: 00085412478364
• UDI-Public: (01)00085412478364
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K872743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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: Other
• Device Catalogue Number: H93813901
• Device Lot Number: 60222887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1