MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE EUROPEAN VALVE SET, EM2400; SET, I.V. FLUID TRANSFER

Catalog Number H938724E

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Event date: the event occurred on an unspecified date of (b)(6) 2019.Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a em2400 valve set had defective primary packaging (peel seam was opened).This issue was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added : the device was manufactured between june 21, 2018 - june 22, 2018.The actual sample was received for evaluation.A visual inspection was performed which observed that the primary packaging was found opened on the right side only.Sufficient sealing appeared to have been observed on the opened seam section of the primary packaging.Top and bottom seals were not opened and no defect was observed of the valve set.The reported problem was verified.The cause of the reported condition 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: EUROPEAN VALVE SET, EM2400
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE ¿ ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE ¿ ROUND LAKE; 25212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9106217
• MDR Text Key: 159712786
• Report Number: 1416980-2019-05202
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938724E
• Device Lot Number: 60133948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1