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

Model Number 309649

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/18/2022

Event Type  malfunction  

Event Description

It was reported that the bd luer-lok¿ tip syringe plunger stopper released 3,4-dimethoxybenzaldehyde that caused an impurity peak in the chromatography analysis.The following information was provided by the initial reporter: "the customer uses the syringes mentioned below for chromatography.He has noticed that possibly the plunger is releasing a substance that generates a peak in the chromatography analysis.Customer fills the syringes with water based solutions or organic solvents" "in response to the question below, no foreign matter/lubricant-like substances were visually detected on the stopper.However, investigations have shown that 3,4-dimethoxybenzaldehyde is extracted from the stopper (contact between stopper and solvent) and can be seen in the chromatogram.".

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.

Manufacturer Narrative

H6: investigation summary: one photo was received showing chromatography results from a 5ml syringe.The results showed a peak indicating that 3,4-dimethylbenzaldehyde was present at some point.Fourier transform infrared spectroscopy (ftir) was completed on the stopper material and the results stated a close match with polyethylene.3,4-dimethylbenzaldehyde was not present in the results.Potential root cause for the compound cannot be established.The origin of the 3,4-dimethylbenzaldehyde is cannot be confirmed at this time to originated at the manufacturing facility, therefore corrective action is not necessary.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that the bd luer-lok¿ tip syringe plunger stopper released 3,4-dimethylbenzaldehyde that caused an impurity peak in the chromatography analysis.The following information was provided by the initial reporter: "the customer uses the syringes mentioned below for chromatography.He has noticed that possibly the plunger is releasing a substance that generates a peak in the chomatography analysis.Customer fills the syringes with water based solutions or organic solvents" "in response to the question below, no foreign matter/lubricant-like substances were visually detected on the stopper.However, investigations have shown that 3,4-dimethylbenzaldehyde is extracted from the stopper (contact between stopper and solvent) and can be seen in the chromatogram.".

• 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: 13427849
• MDR Text Key: 285681316
• Report Number: 1213809-2022-00041
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096498
• UDI-Public: 30382903096498
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309649
• Device Catalogue Number: 309649
• Device Lot Number: 1203591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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