MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number EMC3320P

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the packaging of fifteen (15) solution administration sets was broken. This was identified prior to use. There was no patient involvement. No additional information is available.

Manufacturer Narrative

Additional information was added: fifteen (15) devices were received for evaluation. A visual inspection was performed using the naked eye in which an open pouch was observed. The reported condition was verified. The cause of the condition was due to a manufacturing issue. Control measures such as in process testing and product testing are already in place to mitigate this failure mode. 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: SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9849502
• MDR Text Key: 183964738
• Report Number: 1416980-2020-01509
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: EMC3320P
• Device Lot Number: 15J31V296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown