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

Catalog Number 300912

Device Problem Illegible Information (4050)

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

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one photo was provided to our quality team for investigation.The photo displayed four 10ml luer lock syringes inside of individual blister packages.One syringe had no print present, the second syringe had a small part of the scale present halfway up the barrel.The final two syringes had only part of the printed scale present, it was severely skewed and rolled tailing off towards the 2ml mark.The observed missing print conditions were non-conforming per product specification.The physical samples are needed for a more in-depth evaluation into potential events or conditions on the marker that could have contributed to the event.Potential root cause for the scale marking defects is associated with the marking process.These conditions are occurring below their expected frequency so no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 2084418.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 2 bd luer-lok¿ tip syringes had illegible, misaligned scale markings.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the gradation marks are only partly present and also seem to be shifted.".

• 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 ; 8015296192
• MDR Report Key: 15535605
• MDR Text Key: 306322716
• Report Number: 1213809-2022-00629
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903009121
• UDI-Public: (01)00382903009121
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K110771
• 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
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300912
• Device Lot Number: 2084418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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