MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT¿ II - 2-PIECE SYRINGE; PISTON SYRINGE

Catalog Number 300844

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

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 in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.H3.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 25 of the bd discardit¿ ii - 2-piece syringe experienced blood leakage.The following information was provided by the initial reporter: when doctors given injection in patience, blood leakage 2ml-24g discardit syringe.

Event Description

It was reported that 25 of the bd discardit¿ ii - 2-piece syringe experienced blood leakage.The following information was provided by the initial reporter: when doctors given injection in patience, blood leakage 2ml-24g discardit syringe.

Manufacturer Narrative

H6: investigation summary: a photograph was received by bd for evaluation.A quality engineer was able to inspect the photograph for the reported issue of leakage for lot number 3058113 and material number 300844.Based on the received photograph, the defect is confirmed.The device history review (dhr) of material number 300844 with lot number 3058113 was checked and there was no quality notification found on this lot from its production date to its dispatch on date.The investigating team has also used the retention samples for investigating the reported defect.The investigation and simulation were carried out on one retention samples where the investigating team has functionally tested the samples for leakage and the defect was not confirmed on the retention samples.The exact root cause can only be determined if we receive the original sample.

• Brand Name: BD DISCARDIT¿ II - 2-PIECE 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17553472
• MDR Text Key: 321317979
• Report Number: 2243072-2023-01456
• 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,Followup
• Report Date: 08/28/2023

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: 300844
• Device Lot Number: 3058113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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