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

Catalog Number 301285

Device Problem Leak/Splash (1354)

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

Event Date 05/21/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed as the mfr site and the franklin lakes fda registration number has been used for the manufacture report number.Two photos were received by bd for evaluation.A quality engineer was able to review the photo of item #: 301285 from lot#: 2012403 regarding the reported issue of blood leakage.The investigation and simulation were carried out on ten retention samples where the investigating team has visually tested the samples for blood leakage and no blood leakage was found in the ten retention samples.Since no sample and two photographs received were not helpful to investigate further, the complaint could not be confirmed, and investigation could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

Event Description

It was reported that the bd discardit¿ ii syringe had a leakage problem.The following information was provided by the initial reporter: one of the customers has complained the issue over telephone that blood was coming out from the syringes during the time of blood collection.

• 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 ; 8015296192
• MDR Report Key: 14749825
• MDR Text Key: 301269589
• Report Number: 2243072-2022-00831
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• 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
• Date Manufacturer Received: 05/21/2022
• 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