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

Catalog Number 1022-156-032

Device Problem Contamination (1120)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

It was reported that 6 of the bd female luer-lok adapter had foreign matter in fluid pathway.The following information was provided by the initial reporter, translated from spanish to english: the purpose of this email is to notify us that our production team reported 6 pieces with the female luer with dirt, the total order was processed, so we only need you to help us take corrective actions such as checking inventories, root cause.

Manufacturer Narrative

Date of event: unknown.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.Device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that 6 of the bd female luer-lok adapter had foreign matter in fluid pathway.The following information was provided by the initial reporter, translated from spanish to english: the purpose of this email is to notify us that our production team reported 6 pieces with the female luer with dirt like shown in the photo below, the total order was processed, so we only need you to help us take corrective actions such as checking inventories, root cause.

Manufacturer Narrative

H6: investigation summary a complaint of adaptors being received with dirt on them was reported by the customer.Photos were provided by the customer that show the product.Foreign matter could not be seen in the photo.A device history review was performed for part 1022-156-032.From the dhr review of lot no.2256443, there was no recorded activity associated with this condition.Additionally, there were 13 in-process inspections performed that totaled 832 total parts inspected with 0 defects noted for batch number 2256443.The complaint cannot be confirmed as the image provided does not display any foreign matter, and physical samples have not been provided.

• Brand Name: BD FEMALE LUER-LOK 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: 16067426
• MDR Text Key: 308483012
• Report Number: 9616066-2022-02092
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1022-156-032
• Device Lot Number: 2256443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• 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