MAUDE Adverse Event Report: PLASTICOS Y MATERIAS PRIMAS PYMPSA SYRINGE INLET, NON-STERILE SET, I.V. FLUID TRANSFER

Catalog Number H938176

Device Problems Cap (424); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Manufacturer Narrative

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

Event Description

This report summarizes 1 malfunction events. It was reported that a micro-volume syringe inlet had a ¿stain on the cap on the end of the part connected to the valve set. ¿ this was noted before use. The device packaging had not been opened. There was no patient involvement. No additional information is available.

• Brand Name: SYRINGE INLET, NON-STERILE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): PLASTICOS Y MATERIAS PRIMAS PYMPSA; guadalajara, jalisco
• Manufacturer (Section G): PLASTICOS Y MATERIAS PRIMAS PYMPSA; 3609-2 juan de la barrera; parque industrial el alamo; guadalajara, jalisco 44490 ; MX 44490
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8016994
• MDR Text Key: 125438177
• Report Number: 1416980-2018-06935
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (Y/N): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/29/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: No
• Device Operator: NO INFORMATION
• Device Catalogue Number: H938176
• Device LOT Number: 802418
• Was Device Available For Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/31/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage