MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP; SET, I.V. FLUID TRANSFER

Catalog Number H938738

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

Event Type  malfunction  

Event Description

It was reported that particulate matter (pm) was observed within a 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag.The pm was further described as a small, hair-like, thin particle.This was identified during visual inspection of the finished product prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction expiration date (omitted on initial).One actual device and one photograph was received for evaluation.The device was partially filled with an unspecified solution.A visual inspection of the actual device with the unaided eye and with magnification did not identify any abnormalities that could have contributed to the reported condition.The fill port cap was removed and no issue was observed in the connector or cap area of the actual sample.Analysis of the photo image found a white polymeric appearing elongated particle possibly of acrylonitrile butadiene styrene material observed in fluid path.The reported condition was verified in the photograph, however, was not verified in the actual sample.The cause of the condition could not be determined; however, possible causes include compounding error, during customer handling, or inherent to the manufacturing process.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: EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16413088
• MDR Text Key: 310157183
• Report Number: 1416980-2023-00605
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477220
• UDI-Public: (01)00085412477220
• Combination Product (y/n): N
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938738
• Device Lot Number: 60377980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NA.