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

Catalog Number 300850

Device Problem Crack (1135)

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

Event Date 10/30/2021

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 the (b)(4) fda registration number has been used for the manufacture report number.Investigation summary: the photo was received by bd for evaluation.A quality engineer was able to review the photo of a discardit 5ml from lot # 1220332 regarding item # 300850 with the reported issue of ¿crack in the barrel while withdrawing blood via cannula¿.The dhr of material number 300850 and lot number 1220332 was checked and no quality notifications were recorded on this lot.No samples 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 300850 and lot number 1220332 for investigating the reported defect.None of the ten retention samples showed any crack barrel on visual inspection.The received photograph was investigated for the reported defect of crack barrel.The photograph confirmed the defect on visual inspection.The defect is confirmed.The probable root cause of crack barrel is due to the process of 2ml online barrel transfer from molding area to the hopper that processes them further to assembly and packaging.The cracking of the barrel was observed while simulating this process.It was found that when cold barrels (stored in poly) are mixed along with online barrels, there is a temperature variation of hot and cold barrels as they are passing through the pneumatic shoot.As a corrective action the following two steps have been taken: the temperature variation causing the frequent changing of pneumatic pressure silo will be fixed having capacity of approx.70000 syringes.This silo will store the material before transferring to machine, this will now ensure that the barrels will all have a uniform cold temperature when its moving in the pneumatic shoot towards the machine.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and no capa is required at this time.

Event Description

It was reported that 3 bd discardit¿ ii syringes had cracked barrels.The following information was provided by the initial reporter: "5ml discardit syringe has developed a crack in the barrel while withdrawing blood via cannula.".

• Brand Name: BD DISCARDIT¿ II SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12869799
• MDR Text Key: 286262458
• Report Number: 2243072-2021-02816
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300850
• Device Lot Number: 1220332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2021
• 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