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

Catalog Number H938175

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an over-labeling issue with a vented micro-volume inlet.The device was incorrectly labeled as the new label was covering the old label.The over label stated that the expiry date was 23 february 2020 and the expiry date on the covered label was july 2018.This event was discovered prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, photographs of the sample were provided for evaluation.The photographs were inspected and it was noted that a carton had two labels, one placed atop the other, with the bottom label showing through the top label.The reported condition was verified.The cause of the reported condition could not be determined.A nonconformance has been opened to address this issue.A batch review was conducted by the third party manufacturer and found one deviation noted during manufacture of the product.This deviation captured a request by the client (baxter) to relabel the product with a new label.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VENTED MICRO 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: 7656000
• MDR Text Key: 113423543
• Report Number: 1416980-2018-04021
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475806
• UDI-Public: (01)00085412475806
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/23/2020
• Device Catalogue Number: H938175
• Device Lot Number: 802282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2018
• 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