MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV GP PLUS BURETTE SET, 60DPM, 3 SS Y; INTRAVASCULAR ADMINISTRATION SET

Model Number 63441E

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the lativian translation of the gp plus burette set, 60dpm, 3 ss y label incorrectly stated that "natural rubber latex" and "dehp" were not part of the material.The following information was provided by the initial reporter: "mistake in the latvian translation of ¿natural rubber latex is not part of the material¿.The latvian translation appears to state that there is also no dehp in the product.This is contrary to the ¿contains dehp¿ symbol located on the dfu.".

Event Description

It was reported that the lativian translation of the gp plus burette set, 60dpm, 3 ss y label incorrectly stated that "natural rubber latex" and "dehp" were not part of the material.The following information was provided by the initial reporter: "mistake in the latvian translation of ¿natural rubber latex is not part of the material¿.The latvian translation appears to state that there is also no dehp in the product.This is contrary to the ¿contains dehp¿ symbol located on the dfu.".

Manufacturer Narrative

Correction: after further review, it was found that is not a 510k product.This complaint will be cancelled.

• Brand Name: GP PLUS BURETTE SET, 60DPM, 3 SS Y
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CFN MEXICO 215 SA DE CV; parque industrial el florido.; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10237669
• MDR Text Key: 208704814
• Report Number: 9616066-2020-02076
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

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: Other
• Device Model Number: 63441E
• Device Catalogue Number: 63441E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 20200612
• Patient Outcome(s): Other