MAUDE Adverse Event Report: BAXTER HEALTHCARE - TIANJIN EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 7N8378

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event occurred on (b)(6) 2018.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a packaging issue with a one-link non-dehp standard bore catheter extension set which compromised the sterility of the product.Before patient use, it was discovered that the set was packaged with an additional winged female luer lock adapter component and the packaging had not sealed completely.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.During visual inspection, damage was observed in sterile the blister packaging due to a pinched set and a second set was found inside the sterile blister package.The reported condition was verified.The cause of the event was determined due 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.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - TIANJIN; tianjin
• Manufacturer (Section G): BAXTER HEALTHCARE - TIANJIN; tiedong road; beichen district; tianjin 30040 2; CH 300402
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7282306
• MDR Text Key: 100527401
• Report Number: 1416980-2018-00882
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412091792
• UDI-Public: (01)00085412091792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/09/2022
• Device Catalogue Number: 7N8378
• Device Lot Number: UR17D09020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• 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