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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLASTICOS Y MATERIAS PRIMAS PYMPSA NON VENTED HIGH VOL.INLET,N/S SET, I.V. FLUID TRANSFER

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PLASTICOS Y MATERIAS PRIMAS PYMPSA NON VENTED HIGH VOL.INLET,N/S SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938173
Device Problems Cap (424); Connector (435); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 05/02/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that moisture was observed in between the spike and cap of two (2) non-vented high-volume inlets which indicated contamination. The contamination was discovered during setup and before use. There was no patient involvement. No additional information is available.

 
Manufacturer Narrative

The two (2) devices were received for evaluation. Visual inspection on the returned samples observed a narrow thin film of silicone residue on the surfaces of the spike and inside surfaces of the cap as it was removed. The reported issue was verified. The cause of the condition was not determined. A batch review was conducted and there were no deviations found related t this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.

 
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Brand NameNON VENTED HIGH VOL.INLET,N/S
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 Key7545491
MDR Text Key109892028
Report Number1416980-2018-03193
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK002705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 10/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date10/25/2020
Device Catalogue NumberH938173
Device LOT Number802481
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/11/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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