MAUDE Adverse Event Report: BECTON DICKINSON STOPCOCK Q-SYTE WHT 360DEG NONSTERILE; STOPCOCK, I.V. SET

Catalog Number 395240

Device Problem Material Deformation (2976)

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

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f27 ¿ no patient involvement.Product problem code: a0406 - material deformation.

Event Description

This mdr is for the material deformation.Black marks, stain marks, scratches, dents found during production at atom.362 black marks, 22 stain marks, 4 scratches, 10 dents are found.

Manufacturer Narrative

Our quality engineer inspected the 6 photos submitted for evaluation.The issues of foreign matter, bent/deformed component, and cosmetic issues were confirmed upon inspection of the photos.One representative photograph was labeled as "black mark" and dark spots overlaid the stopcock housing.One photograph was labeled as "contamination" and yellow colored material overlaid the top body of the q-syte connector.One photograph was labeled as "damage" and features were observed on the luer adapter of the stopcock housing.One photograph was labeled as "dent" and features were observed on the top body connector that were consistent with a dent.Due to the poor image quality and without the physical samples, it was unclear if the black marks and stain mark were embedded or were a feature on the external surface of the material.Due to the poor image quality and without the physical samples, it could not be determined if the damage and dent were caused during the molding process or from damage from subsequent processing or handling.As the photographs support the complainant¿s description of the reported event, the complaints were confirmed.However, bd cannot confirm the exact cause of the failure since no sample was returned for evaluation.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

Event Description

No additional information received.

• Brand Name: STOPCOCK Q-SYTE WHT 360DEG NONSTERILE
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18175302
• MDR Text Key: 328628806
• Report Number: 9610847-2023-00316
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 395240
• Device Lot Number: 2056810
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1