MAUDE Adverse Event Report: BAXTER HEALTHCARE - CALI PLEXITRON SOLUTION ADMINISTRATION SETS

Catalog Number MRC0001MP

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The initially reported event occurred during the unspecified date of (b)(6) 2019. (b)(6). The device was received for evaluation. A visual inspection was performed which noted that the over pouch was deliberately opened as excessive manipulation was evidenced. Therefore, the reported condition of ¿peel pouch was opened¿ was not verified. However, the visual inspection revealed that the set did not have the blue tip protector that covers the spike (20 drops). Further evaluation revealed this molded piece had incomplete filling caused in the injection molding process. The issue of defective spike connector was verified. The product did not meet specification. The cause of the damage spike connector was due to the machine molding step during 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.

Event Description

It was reported that a plexitron solution administration set (sterile fluid path) had an opened peel pouch. This was identified prior to patient use. There was no patient involvement. No additional information is available.

• Brand Name: PLEXITRON SOLUTION ADMINISTRATION SETS
• Type of Device: PLEXITRON SOLUTION ADMINISTRATION SETS
• Manufacturer (Section D): BAXTER HEALTHCARE - CALI; cali
• Manufacturer (Section G): BAXTER HEALTHCARE - CALI; calle 36 no. 2c-22; apartado aero 2446; cali ; CO
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8784675
• MDR Text Key: 150846270
• Report Number: 1416980-2019-03734
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MRC0001MP
• Device Lot Number: SE18EH9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage