MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD 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	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a black particle was found inside the male luer lock connector of a fluid transfer extension set.This occurred during compounding setup.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection revealed an embedded dark spot in one of the two luer lock caps.The particle was not exposed to the fluid pathway.Microscopic inspection revealed that the particulate matter was approximately 0.05 inches in length.Fourier transform infrared (ftir) spectroscopy and scanning electron microscopy with energy dispersive x-ray spectroscopy (sem-eds) were performed on the particle.A portion of the luer cap was sampled for comparison.Analysis revealed that the particulate matter was comprised of polyethylene and possible other materials or thermal degradation.Analysis of the cap material revealed that the cap was made of polyethylene.The reported condition was verified.The cause of the condition was not determined.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 - ENGLEWOOD; englewood CO
• MDR Report Key: 7361451
• Report Number: 1416980-2018-01507
• Device Sequence Number: 16171417
• Product Code: FMF
• UDI-Device Identifier: 00085412476841
• UDI-Public: (01)00085412476841
• 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): 04/24/2018

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: 12/31/2019
• Device Catalogue Number: H93887
• Device Lot Number: 1205286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1