MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT¿ II SYRINGE; PISTON SYRINGE

Catalog Number 300844

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and (b)(4) fda registration number has been used for the manufacture report number.Investigation summary: the sample was received by bd for evaluation.A quality engineer was able to review the returned sample of (1) discarditii 2ml with 24*1 (b)(4) from lot # 1030341 product # 300844 with the reported issue of ¿significant amount of air enters the syringe while withdrawing medication from vials¿.The dhr of material number 300844 and lot number 1030341 was checked and no quality notifications were recorded on this lot.One sample and one photograph were received from the customer and were used for investigation of the reported defects.The investigation team also used retention samples of material code 300844 and lot number 1030341 for investigating the reported defect.The original sample was investigated and found that air aspiration is from barrel marking graduation area.Root cause is the high stamping pressure.This stamping is adjusted manually by operator as per requirement.The pressure could have gotten high during this lot stamping which damaged the syringe thus leading to air aspirating in the product.As a corrective action a bubble test is introduced to the operators to be performed during the setting of the marking station.Training provided to all operators to perform bubble test whenever setting is done in marking station.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on this, a capa is not needed at this time.

Event Description

It was reported that 3000 bd discardit¿ ii syringes had damaged barrels.The following information was provided by the initial reporter: "customer reported significant amount of air enters the syringe while withdrawing medication from vials".Via bd investigation: "the original sample was investigated and found that air aspiration is from barrel marking graduation area.Root cause is the high stamping pressure.This stamping is adjusted manually by operator as per requirement.The pressure could have gotten high during this lot stamping which damaged the syringe thus leading to air aspirating in the product.".

• Brand Name: BD DISCARDIT¿ II SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12746387
• MDR Text Key: 279928051
• Report Number: 2243072-2021-02653
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300844
• Device Lot Number: 1030341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2021
• 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