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

Catalog Number 301285

Device Problem Fracture (1260)

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

Event Date 06/21/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.(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 barrel of the bd discardit ii¿ syringe with needle cracked prior to the blood collection.This occurred with 16 syringes.The following information was provided by the initial reporter: "discardit 5ml*22g barrel crack prior to use for blood collection".

Event Description

It was reported that the barrel of the bd discardit ii¿ syringe with needle cracked prior to the blood collection.This occurred with 16 syringes.The following information was provided by the initial reporter: "discardit 5ml*22g barrel crack prior to use for blood collection".

Manufacturer Narrative

H6: investigation summary there are no sample and three photograph received along with the reported complaint of crack barrel.The investigating team has used the retention samples of material number 301285 and lot number 2012403 for investigating the reported defect.The investigation and simulation were carried out on ten retention samples where the investigating team has visually tested the samples for crack barrel and no crack barrel was found in the ten retention samples.Based on the photograph the defect is confirmed.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: 1.The temperature variation causing the frequent changing of pneumatic pressure silo will be fixed having capacity of approx.70000 syringes.2.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.

• Brand Name: BD DISCARDIT II¿ SYRINGE WITH NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15058801
• MDR Text Key: 304015947
• Report Number: 2243072-2022-00972
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301285
• Device Lot Number: 2012403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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