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 Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that six (6) non-vented high-volume inlets had been relabeled.This was noted before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual devices were not available; however, a photograph of three of the samples were provided for evaluation.During visual examination of the provided photo, over labeling was observed on three of the units.The reported condition was verified; however, the cause of the condition could not be determined.The other three devices were not returned; therefore, a device analysis could not be completed.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A nonconformance has been opened to address this issue.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: 7639471
• MDR Text Key: 112892562
• Report Number: 1416980-2018-03876
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938173
• Device Lot Number: 802278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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