MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE

Catalog Number 302995

Device Problem Illegible Information (4050)

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

Event Date 03/02/2023

Event Type  malfunction  

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.

Event Description

It was reported that the scale markings rubbed off the bd luer-lok¿ tip syringe, rendering them illegible.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "the markings rubbed off.".

Event Description

It was reported that the scale markings rubbed off the bd luer-lok¿ tip syringe, rendering them illegible.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "the markings rubbed off.".

Manufacturer Narrative

H6: investigation summary: three photos were provided to our quality team for investigation.Upon examination of the returned photos, it was observed that the scale markings from 3ml to 4ml area missing and looks to have been rubbed off.Potential root cause for the missing print defect is associated with the assembly process.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.

• Brand Name: BD LUER-LOK¿ TIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16587491
• MDR Text Key: 312224789
• Report Number: 1213809-2023-00244
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• UDI-Public: 00382903029952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302995
• Device Lot Number: 3013519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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