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

Catalog Number H938176

Device Problem 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.

Manufacturer Narrative

The actual device was received for evaluation.The returned unit was labeled for single use.A visual inspection was performed and noted a dark embedded piece of particulate matter was observed on the inlet connector cap.The reported problem was verified.The cause of the condition could not be determined.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: SYRINGE INLET, NON-STERILE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): PLASTICOS Y MATERIAS PRIMAS PYMPSA; guadalajara, jalisco
• 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

1 Patient was 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
• Date Manufacturer Received: 03/31/2019
• Patient Sequence Number: 1