MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD¿ NON-VENTED MALE LUER LOCK CAP; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 1008-000-004

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2022

Event Type  malfunction  

Event Description

It was reported that 1 bd¿ non-vented male luer lock cap each from lots 0001097691 and 0004167973 were discolored.The following information was provided by the initial reporter: "customer advised of color issue.There is a difference in color of stylet caps".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0001097691.Medical device expiration date: na.Device manufacture date: 29-jul-2017.Medical device lot #: 0004167973.Medical device expiration date: na.Device manufacture date: 19-dec-2020.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary a complaint of discoloration of the non-vented male luer caps was received from the customer.Photos were provided by the customer for investigation.In the photos the component can be seen.Since no physical samples were available for review, the defect cannot be confirmed.Lots 0001097691 & 0004167973 were manufactured by vyaire.The molds have now been moved to the north american molding center (namc), and dhr information could not be obtained from vyaire.A review of quality notifications was performed by namc with no record of discoloration being reported since molding of this component began.Namc will be monitoring this defect in the event of occurrence through the visual and first piece inspection controls placed in production.

Event Description

It was reported that 1 bd¿ non-vented male luer lock cap each from lots 0001097691 and 0004167973 were discolored.The following information was provided by the initial reporter: "customer advised of color issue.There is a difference in color of stylet caps".

• Brand Name: BD¿ NON-VENTED MALE LUER LOCK CAP
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15518720
• MDR Text Key: 306362599
• Report Number: 9616066-2022-01454
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403483974
• UDI-Public: (01)10885403483974
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1008-000-004
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• 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: Initial
• Patient Sequence Number: 1