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

Catalog Number 59006988

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.Oem manufacture: the manufacturing location for this product is greater (b)(4).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.

Event Description

It was reported that the syringe 10ml 23g 1-1/4in experienced cracking.The following information was provided by the initial reporter: barrel is cracked.

Event Description

It was reported that the syringe 10ml 23g 1-1/4in experienced cracking.The following information was provided by the initial reporter: barrel is cracked.

Manufacturer Narrative

1 sample was returned to sbdm, lot number is unknown.Sbdm found crack in the barrel.House sample inspection: sbdm inspected 30 pcs from potential lot 1810224, 1811263, 1901213, no abnormality is observed.Dhr review: sbdm reviewed the manufacturing record for potential lot 1810224, 1811263, 1901213, no abnormality is observed.Customer complaints record review: sbdm reviewed the customer complaint record, there is no same issue from other customer.Corrective actions: 1.Sbdm conducted quality training on this customer complaint for syringe assembly line workers and quality inspector.2.Sbdm improved syringe assembly machine by regulating speed of product feeding guide to prevent reoccurrence of the complaint case.3.Sbdm are strengthening process monitoring & product inspection during syringe assembly & packing process.4.Sbdm implemented 100% visual inspection in syringe assembly & packaging process and had retrained on inspection method for packaging inspector due to this complaint case effective.Conclusion: 1 sample was returned to sbdm, lot number is unknown.From investigations, the likely cause of the cracked barrel may have occurred before the scale printing process.This defect could occur by malfunction of barrel & plunger assembly machine.If the barrels move to assembly machine and there are full of barrels, sensor is working.It means that the feeder and scale printing machine stopped promptly and resume the run again.An error can occur by the time of re-run and then the feeder index hit and broke the barrel.

• 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: 8600443
• MDR Text Key: 145516691
• Report Number: 2243072-2019-00899
• 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: 06/24/2019

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
• Device Operator: Other
• Device Catalogue Number: 59006988
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other