MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SYRINGE AND NEEDLE

Catalog Number 59006488

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the bd¿ syringe and needle had a loose plunger causing leakage during use.

Event Description

It was reported that the bd¿ syringe and needle had a loose plunger causing leakage during use.

Manufacturer Narrative

Investigation summary: one sample was returned to sbdm, lot number is 1809142.Sbdm visually inspected the returned sample, the stopper seems a bit dislodged with plunger inside the barrel.When sbdm push the plunger fully in the barrel, it was noticed the stopper and plunger was in fully assembled condition.Returned sample syringe and needle leakage test: sbdm conducted leakage test using 1 pc returned sample and results are: when pulled straight, the syringe and needle show no leakage or air aspiration.When pulled obliquely, the syringe and needle show no leakage or air aspiration.House sample inspection: sbdm inspected 15 pcs of house samples from lot 1809142, no abnormality was observed.Device history record review: sbdm reviewed the manufacturing record for lot 1809142, no abnormality was observed.Customer complaint record: sbdm review the customer complaint record, there are no same issue from other customer.Corrective actions: sbdm conduct quality training on this customer complaint for syringe assembly line workers and quality inspector.Sbdm improved syringe assembly machine by regulating speed of product feeding guide to prevent reoccurrence of the complaint case.Sbdm will strengthen process monitoring & product inspection during syringe assembly & packing process.Sbdm will implement 100% visual inspection in syringe assembly & packaging process and had retrained on inspection method for packaging inspector.The actions are due 11 jan 2019.Conclusion: 1 sample was returned to sbdm.From investigations, the likely cause is due to loosen gasket which occurred during the plunger and gasket assembly process.This is attributed to temporary malfunction of the assembly machine, in which the gasket and plunger was not fully assembled.The affect sample look normal visually after assembled, thus the inspector could not find the defect.Sbdm has in house capa(b)(4) on file to monitor defect.

• Brand Name: BD¿ SYRINGE AND NEEDLE
• Type of Device: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8240723
• MDR Text Key: 132946375
• Report Number: 2243072-2018-01941
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/13/2021
• Device Catalogue Number: 59006488
• Device Lot Number: 1809142
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other