MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXTENSION SET, PUMP, MLL TO ML; SYRINGE, PISTON

Catalog Number	H93887
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/05/2020
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 there was a fiber inside an unopened sterile package of a fluid transfer extension set.This was identified during setup and prior to use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added: the lot was manufactured from december 17, 2019 - december 18, 2019.The device was received for evaluation.Unaided visual inspection was performed which observed a loose hair approximately 0.3 inches in length inside the sealed packaging of the returned sample, not in the fluid pathway.The reported condition was verified.The cause of the condition was due to a supplier manufacturing issue.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: EXTENSION SET, PUMP, MLL TO ML
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9802015
• Report Number: 1416980-2020-01260
• Device Sequence Number: 2777939
• Product Code: FMF
• UDI-Device Identifier: 00085412476841
• UDI-Public: (01)00085412476841
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/06/2020

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: 11/30/2022
• Device Catalogue Number: H93887
• Device Lot Number: 60220554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1