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

Catalog Number H938173

Device Problem 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.

• Brand Name: NON VENTED HIGH VOL.INLET,N/S
• 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: 7545491
• MDR Text Key: 109892028
• Report Number: 1416980-2018-03193
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475783
• UDI-Public: (01)00085412475783
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/25/2020
• Device Catalogue Number: H938173
• Device Lot Number: 802481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2018
• 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: N
• Patient Sequence Number: 1