MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXPLUS POSITIVE PRESSURE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MP1000-0006

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

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 maxplus positive pressure connector experienced incorrect label information.The following information was provided by the initial reporter: we have detected on device# " mp1000-c0006 " a non-conformity concerning the labeling.As there is an error of identification, the cardboard labeling of the batches indicate a ce2797 marking number while the product labeling indicates the ce0086 marking number.Furthermore, we have also noticed that for the same batch of product there are products with different supplier names.

Manufacturer Narrative

H6: investigation summary an mp1000c-0006 sample was not required for investigation of this feedback as the customer provided photographs of the affected sample analysis of the photographs confirmed the customer's experience with a difference in the ce marking number between the bulk packaging and the product packaging of the mp1000c-0006.The details of this feedback were forwarded to the manufacturing site for investigation.They confirmed that the correct ce mark was ce2797, which was printed on the label of the bulk packaging.In this instance it appears that the obsoleted printing plate of the individual packaging of the product had not been disposed of, which resulted in it being inadvertently used during the manufacture of this lot.A review of the production records for lot 20026007 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

Event Description

It was reported that the maxplus positive pressure connector experienced incorrect label information.The following information was provided by the initial reporter: we have detected on device# " mp1000-c0006 " a non-conformity concerning the labeling.As there is an error of identification, the cardboard labeling of the batches indicate a ce2797 marking number while the product labeling indicates the ce0086 marking number.Furthermore, we have also noticed that for the same batch of product there are products with different supplier names.

• Brand Name: MAXPLUS POSITIVE PRESSURE CONNECTOR
• 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: 11345436
• MDR Text Key: 260453354
• Report Number: 9616066-2021-50252
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K072542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/14/2022
• Device Catalogue Number: MP1000-0006
• Device Lot Number: 17066363
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1