MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML 23G 1-1/4IN

Catalog Number 59006988

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is greater asia.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that syringe 10ml 23g 1-1/4in had foreign matter.This was discovered during use.The following information was provided by the initial reporter: foreign matter (plastic).

Manufacturer Narrative

H.6.Investigation summary: one sample was returned to sbdm, lot number is unknown.From visual inspection, the fm is a piece of plastic, which might be broken tip of barrel.Infrared spectrometry (ir) analysis: from ir analysis, the fm was determine to be polypropylene+poly(ethylene:propylene) which is copolymer of polypropylene & poly(ethylene:propylene), the same raw material of barrel (polypropylene is a raw material of the barrel & plunger.House sample inspection: sbdm inspected 30 pcs house samples from 3 possible lot numbers (1907104, 1908084 & 1910112) of the complaint sample, there was no issue.Dhr review: sbdm reviewed the manufacturing record from 3 possible lot numbers (1907104, 1908084 & 1910112) of the complaint sample, no abnormality observed.Customer complaint record review: sbdm reviewed the customer complaint record of complaint sample, there is no same issue of the same product from other customer.Root cause: from investigation, the fm between the stopper and barrel occurred in the syringe assembly process.The fm was assumed to be broken tip of barrel which occurred in the 10ml supply process.When the barrel was supplied in the supply chamber the tip was caught in the conveyor, causing it to break.The broken tip of barrel got into the barrel in the chamber and supplied into the assembly machine.However, the inspector could not find the fm on the stopper and it caused the complaint case.Corrective actions: 1.Sbdm conducted quality training on this customer complaint for syringe assembly line workers for line cleaning and quality inspectors.2.Sbdm implemented tightened product & process inspection and strengthening quality inspection for syringe manufacturing process.3.Sbdm maintained the index of syringe assembly machine to fit between feeder and index.4.Sbdm implemented 100% visual inspection on syringe packaging process and we also had retrained on inspection method for packaging inspector due to this complaint case effective.Sbdm has in house capa(b)(4) in place to monitor trend.H3 other text : see section h.10.

Event Description

It was reported that syringe 10ml 23g 1-1/4in had foreign matter.This was discovered during use.The following information was provided by the initial reporter: foreign matter (plastic).

• Brand Name: SYRINGE 10ML 23G 1-1/4IN
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9537000
• MDR Text Key: 178026595
• Report Number: 2243072-2019-02930
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 59006988
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other