MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ADPTR,TUBE SET TO BAG,STER; SYRINGE, PISTON

Catalog Number	H93884
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a particle was observed in the sterile packaging of a luer lock-to-bag-adapter.The issue was identified before use; during the pre-compounding check prior to opening the package.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Received one (1) unopened sample.Unaided eye visual inspection was done under normal room conditions which observed brown foreign matter embedded under a sealed corner area of the primary packaging only.The reported condition was verified.The cause of the condition could not be determined; however, the issue most likely occurred somewhere in the packaging process during the manufacturing process.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: ADPTR,TUBE SET TO BAG,STER
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; 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: 15635911
• Report Number: 1416980-2022-05613
• Device Sequence Number: 7141685
• Product Code: FMF
• UDI-Device Identifier: 00085412476827
• UDI-Public: (01)00085412476827
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K872743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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: 02/28/2025
• Device Catalogue Number: H93884
• Device Lot Number: 60357791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown