MAUDE Adverse Event Report: BECTON DICKINSON BD 2 PC 5 ML SYRINGE - DISCARDIT II 24G×1; PISTON SYRINGE

Catalog Number 300847

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/06/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is bawal.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections and the franklin lakes fda registration number has been used for the manufacture report number.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd 2 pc 5 ml syringe - discardit ii 24g×1 there was leakage.There was no report of patient impact.The following information was provided by the initial reporter: drug is leaking from the sides of the plunger.

Event Description

It was reported while using bd 2 pc 5 ml syringe - discardit ii 24g×1 there was leakage.There was no report of patient impact.The following information was provided by the initial reporter: drug is leaking from the sides of the plunger.

Manufacturer Narrative

Investigation summary: the photo was received for evaluation.A quality engineer was able to review the photo of a discardit ii 5ml with 24x1 from lot number 2271979 regarding material number 300847 with the reported issue that air bubbles, leakage, plunger movement difficulty.The device history review of material number 300847 with lot number 2271979 was checked and there was no quality notification found on this lot from its production date to till end of dispatch.The investigation and simulation were carried out on two retention samples where the investigating team has used one sample for plunger movement force and plunger movement force was found with in limit.The other sample was tested for leakage and no leakage was observed in the sample.The investigating team has visually checked the samples for air bubbles and no air bubble were found in the retention samples.The exact root cause can only be determined if we receive the original sample.

• Brand Name: BD 2 PC 5 ML SYRINGE - DISCARDIT II 24G×1
• 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: 16607599
• MDR Text Key: 312124803
• Report Number: 2243072-2023-00456
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903008476
• UDI-Public: (01)00382903008476
• 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: 04/27/2023

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: 300847
• Device Lot Number: 2271979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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