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

Catalog Number	H93884
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/27/2020
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 an unspecified quantity of luer lock-to-bag-adapter internal thread was contaminated.It was further specified that the packaging was wet.This issues was identified during setup and preparation there was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: the lot was manufactured from february 20, 2020 - february 21, 2020.H10: three (3) actual samples were received for evaluation.Unaided visual inspection was performed which observed contaminated dark/transparent areas of the primary packaging on the back side and seen through on the front side of all samples.The cause of the condition was not determined.Functional testing was not performed for this complaint.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
• MDR Report Key: 10179569
• Report Number: 1416980-2020-03490
• Device Sequence Number: 17037309
• Product Code: FMF
• UDI-Device Identifier: 00085412476827
• UDI-Public: (01)00085412476827
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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 Expiration Date: 01/31/2023
• Device Catalogue Number: H93884
• Device Lot Number: 60228301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1