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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that particulate matter (pm) was observed on the connector of an unspecified quantity of rapidfill connectors.The pm was further described as, ¿small black flakes on connector¿.The pm was observed during preparation prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Initial reporter city -(b)(6).Initial reporter phone no.- (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction: g3: date received by mfr in the initial mdr was inadvertently submitted as 5/10/2022; this is being corrected to 07/04/2022.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H4: the lot was manufactured from december 15, 2021 - december 16, 2021.H10: the actual devices were not available; however photo of an actual sample was received for evaluation (lot was not documented in the photo).Visual inspection was performed to the photograph which showed black flakes on the photo of the connector.The reported condition was verified on the photograph.The cause of the condition could not be determined.Additionally, seven (7) unopened companion samples were received for evaluation.Visual inspection along with magnification was performed which did not identified any abnormalities that could have contributed to the reported condition; no particulate matter was identified.The reported condition was not verified on the companion samples.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
• Manufacturer (Section G): ECM - AVAILMED S.A. DE C.V. - SP021332; c. industrial lt 001 mz 105; no 20905 int a, col cd ind; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15157544
• Report Number: 1416980-2022-04018
• Device Sequence Number: 12111298
• Product Code: FMF
• UDI-Device Identifier: 00085412478364
• UDI-Public: (01)00085412478364
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2022

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: 11/30/2024
• Device Catalogue Number: H93813901
• Device Lot Number: 60338744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 09/01/2022; 09/07/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/01/2022; 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown