MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 1000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938739

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a white foreign material was observed on the fill port cap of forty-two (42) 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags.This issue was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d4 (lot #/expiration date/udi), d10, g1 address, h3, h4 and h6.Correction to e1 address.H4: lot manufactured between august 28, 2019 to august 29, 2019.H10: forty-two (42) devices were received for evaluation.All samples were visually inspected and loose white foreign matter was observed inside the bag of only one (1) sample; two (2) samples were observed with fill port cap damage.The foreign matter was further isolated and analyzed using micro-fourier transform infrared (ftir) spectroscopy with a microscope module.The ftir analysis determined the spectrum of the particle was consistent with acrylonitrile butadiene styrene (abs).The fill port and fill port cap are molded from abs.Unaided visual and magnified inspection did not identify any abnormalities that could have contributed to the reported condition on the remaining thirty-nine (39) samples; the reported condition was not verified for these samples.However, the reported condition was verified for 1 sample.The cause of the foreign matter and observed fill port cap damage could not be 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: 1000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10089983
• MDR Text Key: 192145669
• Report Number: 1416980-2020-02932
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: H938739
• Device Lot Number: 60202712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 07/22/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1