MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE IN THE BULK STERILE CONVENIENCE PAK; PISTON SYRINGE

Catalog Number 309605

Device Problems Illegible Information (4050); Missing Information (4053)

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

Event Date 01/23/2023

Event Type  malfunction  

Manufacturer Narrative

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 329 bd luer-lok¿ tip syringes in the bulk sterile convenience pak had either missing or double-printed scale markings that rendered them illegible.The following information was provided by the initial reporter: "on (b)(6) 2023 during visual inspection there were 329 syringes found with missing ink or double printed.".

Manufacturer Narrative

H6: investigation summary six samples and seven photos were provided to our quality team for investigation.Through visual inspection, it was observed that three of the samples have a double image on the numbers and bd logo of the scale markings, however; the markings are legible.Three of the samples have missing print in the scale markings area on the numbers and major and minor graduation lines consistent with being scraped off.One of the photos shows a loose syringe have five hairline ink rings in the scale markings area of the barrel.The ink rings and missing print conditions observed are non-conforming per product specification.Potential root cause for the ink ring defect is associated with the marking process and missing print is associated with the assembly process.A notification for these defects were written during the production of this batch.A requalification was performed, and the line cleared of defects.However, it is possible a limited number of pieces with this condition were able to escape detection.H3 other text : see h10.

Event Description

It was reported that 329 bd luer-lok¿ tip syringes in the bulk sterile convenience pak had either missing or double-printed scale markings that rendered them illegible.The following information was provided by the initial reporter: "on 01/23/23 during visual inspection there were 329 syringes found with missing ink or double printed".

• Brand Name: BD LUER-LOK¿ TIP SYRINGE IN THE BULK STERILE CONVENIENCE PAK
• 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: 16427785
• MDR Text Key: 310347639
• Report Number: 1213809-2023-00110
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096053
• UDI-Public: 00382903096053
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309605
• Device Lot Number: 2094839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• 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