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

Catalog Number	H93884
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the packaging of an unspecified quantity of luer lock-to-bag-adapters internal thread was damaged; further described as "looks transparent and air is now easily escaping the package."this was observed prior to use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The lot was manufactured between may 13, 2021 - may 17, 2021.The actual device was not available; however, a photograph of the sample was provided for evaluation.  visual inspection was performed to the photograph using the naked eye which revealed darkened/transparent areas around the sealed section of the primary packaging label side.The reported condition was verified.  by the nature of the sample, no additional tests were performed.  the cause of the condition was due to a sealing/label issue that occurred during the packaging 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: 15412003
• Report Number: 1416980-2022-04782
• Device Sequence Number: 17555943
• Product Code: FMF
• UDI-Device Identifier: 00085412476827
• UDI-Public: (01)00085412476827
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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: 04/30/2024
• Device Catalogue Number: H93884
• Device Lot Number: 60297280
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/25/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown