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	03/02/2021
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 luer lock-to-bag-adapter internal thread had a hair in the packaging.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
B3: event date: during follow up, it was clarified that the event occurred on (b)(6) /2021.E1: initial reporter address: (b)(6) (previously submitted as ni) e1: initial reporter city: (b)(6) (previously submitted as ni) e1: initial reporter postal code: (b)(6) h4: the lot was manufactured from (b)(6) , 2020 - (b)(6) , 2020.H10: the device was received for evaluation.Visual inspection was performed and a loose hair was observed inside the sealed sterile package.The hair was approximately 1.5 inches, not touching the product, and not in the fluid pathway.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause 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: ADPTR,TUBE SET TO BAG,STER
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11569210
• Report Number: 1416980-2021-01609
• Device Sequence Number: 17181351
• Product Code: FMF
• UDI-Device Identifier: 00085412476827
• UDI-Public: (01)00085412476827
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 07/31/2023
• Device Catalogue Number: H93884
• Device Lot Number: 60251808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.