MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE, 1 ML; PISTON SYRINGE

Catalog Number 309648

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

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

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd luer-lok¿ syringe, 1 ml contained foreign matter.The following information was provided by the initial reporter: "while packing the syringes we come across syringes where we see quite a bit of silicone oil in the syringe.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-18.Investigation summary: three photos were received and evaluated.The photos appeared to show five loose 1ml ll syringes in total.All syringes in the photos were observed to have liquid pooling behind the stopper outside the fluid path.The liquid was likely silicone.The excess silicone pooling behind the stopper is a non-conforming condition per product specification.Seven loose 1ml ll syringes were received and were visually evaluated.All seven syringes were observed to have silicone pooling behind the stopper outside the fluid path.All syringes had silicone overspray on the top of the flanges and plunger rods were covered in silicone, with quantity increasing closer to connection with stoppers.The plungers were pulled back and fluid path evaluated.Stopper surface of all seven syringes was ¿wet¿ from silicone.Silicone pooling >50% around the edge of the stopper was observed in the samples.The amount of silicone observed in the fluid path was excessive and non-conforming per product specification.Potential root cause for the excess silicone defect is associated with improper setup and potential equipment failure.It is possible improper positioning of the silicone gun led to silicone overspray on the barrel flanges and the plunger rods prior to them being completely inserted into barrels.It is possible the silicone gun was defective and was allowing excess amounts of silicone to be sprayed.Failure to contain defect.It is possible the defect was not detected during regular hourly inspections.The following corrective actions are being taken to address excess silicone for product produced on this machine.Exception will be opened to investigate potential root causes of the manufacturing failure and detection failure, and to implement corresponding corrective actions.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.H3 other text : see h10.

Event Description

It was reported that bd luer-lok¿ syringe, 1 ml contained foreign matter.The following information was provided by the initial reporter: " while packing the syringes we come across syringes where we see quite a bit of silicone oil in the syringe.".

• Brand Name: BD LUER-LOK¿ SYRINGE, 1 ML
• 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: 12640058
• MDR Text Key: 276699397
• Report Number: 1213809-2021-00713
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309648
• Device Lot Number: 1127514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2021
• 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