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

Catalog Number	309657
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that clear, oil-like liquid came out of the syringe 3ml ls 200 s/c needle when pressing the plunger before use.The following information was provided by the initial reporter: "spouse reported when his wife pushed on plunger, clear liquid came out onto needle.Stated consistency was like "oil".".
Additional Manufacturer Narrative
Correction: the catalog and lot numbers have been updated.The following information has been corrected: describe event or problem: it was reported that clear, oil-like liquid came out of the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip needle when pressing the plunger before use.The following information was provided by the initial reporter: "spouse reported when his wife pushed on plunger, clear liquid came out onto needle.Stated consistency was like "oil"." medical device brand name: bd luer-lok¿ disposable syringe with bd luer-lok¿ tip medical device catalog#: 309657 medical device lot#: 8244745 medical device expiration date: 2023-08-31 unique identifier (udi) #: (b)(4).Device manufacture date: 2018-09-01.
Event or Problem Description
It was reported that clear, oil-like liquid came out of the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip needle when pressing the plunger before use.The following information was provided by the initial reporter: "spouse reported when his wife pushed on plunger, clear liquid came out onto needle.Stated consistency was like "oil".
Event or Problem Description
It was reported that clear, oil-like liquid came out of the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip needle when pressing the plunger before use.The following information was provided by the initial reporter: "spouse reported when his wife pushed on plunger, clear liquid came out onto needle.Stated consistency was like "oil".
Additional Manufacturer Narrative
Investigation: one opened package from batch #8244745 (p/n 309657) and one loose 3ml syringe with a customer¿s needle attached were received and visually evaluated.The syringe did not appear to have been used.The plunger was pulled back and large amount of silicone was observed pooling on the stopper surface and stringing from the roof of the barrel.The amount of silicone observed is excessive per product specification.Paper part of the package close to the location of the tip appeared to be soaked with silicone residue as well.Furthermore, 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.Machine logs indicate a defective silicone gun was detected and repaired around the manufacture time of this batch.Potential root cause for excess silicone is associated with defective silicone gun during the assembly process.Actions were taken at the time the defect was discovered and the root cause was addressed.It is possible a limited number of product with excessive silicone was not contained and got mixed in with good product.

• Brand Name: BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8556009
• Report Number: 1213809-2019-00478
• Device Sequence Number: 2292665
• Product Code: FMF
• UDI-Device Identifier: 30382903096566
• UDI-Public: 30382903096566
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 309657
• Device Lot Number: 8244745
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019; 04/11/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/14/2019; 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other