MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE SYRINGE INLET, NON-STERILE; SET, I.V. FLUID TRANSFER

Catalog Number H938176

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The event occurred on an unspecified date of 2019.Devices have been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that twenty-six (26) exactamix syringe inlets presented a defect in the sealing of the primary packaging.This was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : twenty-six (26) actual samples were received for evaluation.A visual inspection was performed and observed that the bottom primary packaging seal was opened for all samples.The reported condition was verified.The cause of the 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: SYRINGE INLET, NON-STERILE
• 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; 125212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8814081
• MDR Text Key: 151850205
• Report Number: 1416980-2019-03918
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475813
• UDI-Public: (01)00085412475813
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

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: 08/15/2020
• Device Catalogue Number: H938176
• Device Lot Number: 802418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2017
• 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