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

Catalog Number 1001-143-022

Device Problem Break (1069)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is molding coe.This site is an oem manufacturing site.(b)(4).Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd luer-lock¿ male adapter broke during the removal.The following information was provided by the initial reporter: "after administration of an anticancer drug(docetaxel), 1001-143-022 was broke during removal.There were no external factors such as adhesive effects or impact.When break occurred was there any leakage of the anti-cancer drug? no.If so, was anyone exposed adversely to the leak? no.Was any medical intervention required? no".

Event Description

It was reported that the bd luer-lock¿ male adapter broke during the removal.The following information was provided by the initial reporter: "after administration of an anticancer drug(docetaxel), 1001-143-022 was broke during removal.There were no external factors such as adhesive effects or impact.When break occurred was there any leakage of the anti-cancer drug? ¿ no if so, was anyone exposed adversely to the leak? ¿ no was any medical intervention required? ¿ no".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 03-mar-2023.H6: investigation summary a complaint of broken male luer was received from the customer.Samples were sent back to namc for review.The samples were investigated, along with the molding and process group, and there is no condition present during namc's molding process that would be related to this type of defect.Lot 1074981 had a satorius moisture analyzer check each shift to ensure the resin used to create the male ll adaptor parts were acceptable.All analyzer checks passed for this lot.Along the part there is a white, stress fracture in cold state after it was fully assembled.If the part damage came from the molding process, the part would display damage on the top of the luer.The male ll adaptor was noted to be threaded onto the component extremely tight.Namc does not assemble the component and there is no indication that this defect is a molding defect, therefore this defect cannot be confirmed.There have been no quality notifications for this batch that was related to this condition of "damaged/ broken" for material 1001-143-022 and lot 1074981.This incident has been added to our database of reported incidents.

• Brand Name: BD LUER-LOCK¿ MALE ADAPTER
• 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: 16080784
• MDR Text Key: 306832403
• Report Number: 2243072-2022-02258
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1001-143-022
• Device Lot Number: 1074981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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