MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-DAY LL VLV ADPT(STAND ALONE); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2000E7D

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the barcode/ean number on the 7-day ll vlv adpt(stand alone) box did not match the registered one.The following information was provided by the initial reporter, translated from (b)(6) to english: "the barcode on the product box does not match the registered one.Consumer sent photo with the correct barcode and the incorrect barcode"."customer is complaining about the ean number.Once in the past they received the product with ean code: (b)(4) and now the same product with ean (b)(4)." "customer informed - it is due to the divergence in the bar code, as i have (b)(4) in stock and (b)(4) was sent in this invoice, with this, we are not able to continue with the entry of the item in our stock because it conflicts with the previous registration.".

Event Description

It was reported that the barcode/ean number on the 7-day ll vlv adpt(stand alone) box did not match the registered one.The following information was provided by the initial reporter, translated from portuguese to english: "the barcode on the product box does not match the registered one.Consumer sent photo with the correct barcode and the incorrect barcode" "customer is complaining about the ean number.Once in the past they received the product with ean code: 27613203013929 and now the same product with ean 27613203013622." "customer informed - it is due to the divergence in the bar code, as i have 27613203013929 in stock and 27613203013622 was sent in this invoice, with this, we are not able to continue with the entry of the item in our stock because it conflicts with the previous registration.".

Manufacturer Narrative

H.6.Investigation: a sample was not required for investigation of this feedback as the customer indicates that the barcode and ean number was different on two lots of 2000e7d.The customer provided two photographs of the affected products, analysis of the photographs identified that lot 1017152 had the alleged incorrect ean and 2d qr barcode, whereas lot 1013190 had the alleged correct ean and traditional linear barcode.The details of this feedback were shared with the product engineering and bd regulatory teams and they confirmed that in august 2019 bd updated the labels of a number of products, which included the 2000e7d.This change included moving from a linear barcode to the new 2d qr barcode.These updates have been implemented as a result of the requirements for the scan4safety project and the gs1 standard.As a result of this change, the ean number has also been modified to take into account this new labelling revision.H3 other text : see h.10.

• Brand Name: 7-DAY LL VLV ADPT(STAND ALONE)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 11103532
• MDR Text Key: 251100895
• Report Number: 9616066-2020-20715
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 2000E7D
• Device Lot Number: 1017152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1