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U.S. Department of Health and Human Services

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

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PLASTICOS Y MATERIAS PRIMAS PYMPSA SYRINGE INLET, NON-STERILE SET, I.V. FLUID TRANSFER Back to Search Results
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.

 
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Brand NameSYRINGE INLET, NON-STERILE
Type of DeviceSET, 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 Key8016994
MDR Text Key125438177
Report Number1416980-2018-06935
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Number of Events Reported1
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 Received10/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue NumberH938176
Device LOT Number802418
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2019
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

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