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

Model Number 309628

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/03/2021

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 yellow foreign matter was found on the bd luer-lok¿ tip syringe's plunger rod during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "a yellow foreign matter was found on the syringe plunger rod during the use of the syringe".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/3/2021.H.6.Investigation: two photos and one loose 1ml ll syringe were received at bd vernon hills.Sample sent to bd franklin lakes for fourier transform infrared spectroscopy (ftir) and photo sent to bd canaan for evaluation.The two photos appeared to show parts of the same syringe from different angles.The stopper was at the barrel step position past nominal capacity line.The plunger rod was observed to have four spots of yellow foreign matter outside the fluid path.Foreign matter spot appeared to be non-conforming per product specification.Fourier transform infrared spectroscopy (ftir) analysis was concluded to most likely be silicone lubricant used in the assembly process.Potential root cause for the foreign matter defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch 8277849 is considered in compliance with our product specification requirements.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 yellow foreign matter was found on the bd luer-lok¿ tip syringe's plunger rod during use.The following information was provided by the initial reporter, translated from chinese to english: "a yellow foreign matter was found on the syringe plunger rod during the use of the syringe".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12580814
• MDR Text Key: 274965585
• Report Number: 1213809-2021-00695
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 8277849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• 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