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

Catalog Number 300852

Device Problem Air/Gas in Device (4062)

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

Event Date 03/16/2023

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is bawal, india.This site is not registered with the fda.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Investigation summary: no sample or photograph was received for the complaint ¿blood excess/ splash/spill/ exposure¿.There are no sample and no photograph available, so reported defect cannot be confirmed.The device history review of discardit 5ml 23g material number.300852 with lot number 2360724 was checked and there was no quality notification found on this lot number from its production date to till end of dispatch.Hemolysis resulting from phlebotomy may be caused by incorrect needle size, improper tube mixing, incorrect filling of tubes, excessive suction, prolonged tourniquet, and difficult collection.The exact root cause can only be determined if we receive the original sample.The root cause cannot be determined.The complaint cannot be investigated further.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

It was reported that 100 of the bd discardit¿ ii syringes were hemolyzed while collecting sample.The following information was provided by the initial reporter.Customer is end user and running a path lab, he is facing issue while blood draw (sample collection).While collecting sample with 5ml 23g sample gets hemolyzed.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16687165
• MDR Text Key: 313217334
• Report Number: 2243072-2023-00567
• 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: 03/22/2023

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: 300852
• Device Lot Number: 2360724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2023
• Initial Date FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2022
• 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