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

Catalog Number 302438

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/11/2022

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 and the franklin lakes fda registration number has been used for the manufacture report number.Investigation summary: the ten photos were received by bd for evaluation.A quality engineer was able to review the photo of a discardit 2ml with 25gx1 needle from lot #2150646 regarding item # 302438 with the reported complaint of multiple defects (black spot, foreign particles, and hair particles) in the syringe.The investigating team has used the retention samples of lot #2150646 regarding item # 302438 for investigating the reported defect.The investigation and simulation were carried out on retention samples where the investigating team has visually tested the samples for defects no defect in syringe was found in the retention samples.The investigation was also carried out on the photograph as well.The photograph confirms the reported defect in the syringe.The dhr of material no.302438 with batch no.2150646 was checked and there was no quality notification found on this lot no.

Event Description

It was reported that foreign matter was found in 11594 bd discardit¿ syringes.This complaint was created to capture the 6th of 6 related incidents.The following information was provided by the initial reporter: "15750 units having defects like black spot, foreign particles.And hair particles.".

• Brand Name: BD DISCARDIT¿ 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: 15794843
• MDR Text Key: 307585924
• Report Number: 2243072-2022-01950
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302438
• Device Lot Number: 2150646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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