MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD DISCARDIT II SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 302438

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd discardit ii syringe had foreign matter the following information was received by the initial reporter with the following verbatim: - particle observed in the syringe after reconstitution of rabies vaccine.Customer received the complaint samples from the complainant.The preliminary review of the particle revealed that the particle appear to be from syringe barrel itself.To confirm the same, identification of suspended particle/artifact was done by ftir at qc.Ftir of suspended plastic particle matches with ftir spectrum of syringe barrel.This confirms the that the particle is from syringe barrel itself.This analysis is done by customer - (b)(6).

Manufacturer Narrative

01 samples & 02 photographs received from the customer along with the complaint for the reported issue of ¿suspended plastic particle inside 2ml discardit syringe barrel, ftir of suspended plastic particle matches with ftir spectrum of syringe barrel¿ with lot number 2256709 regarding item # (b)(4).05 retention samples were used for testing of white flakes.No, any types of white partials were found in the syringe.The dhr of batch code 2256709 & material 302438 was reviewed to identify if there is any issue during production of above-mentioned lot.All log sheets of molding, assembly and packaging were reviewed, and no issue observed related to suspended plastic particle in barrel of 2ml discardit syringe.

Event Description

Bd discardit ii syringe-2 ml 25 g x 1" - particle observed in the syringe after reconstitution of rabies vaccine.Customer received the complaint samples from the complainant.The preliminary review of the particle revealed that the particle appear to be from syringe barrel itself.To confirm the same, identification of suspended particle/artifact was done by ftir at qc.Ftir of suspended plastic particle matches with ftir spectrum of syringe barrel.This confirms the that the particle is from syringe barrel itself.This analysis is done by customer - serum institute india pvt ltd.

• Brand Name: BD DISCARDIT II SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18567985
• MDR Text Key: 333539897
• Report Number: 2243072-2024-00057
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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: Lay User/Patient
• Device Catalogue Number: 302438
• Device Lot Number: 2256709
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1