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

Catalog Number 300844

Device Problem Leak/Splash (1354)

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

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: the manufacturing location for this product is bawal.This site is an oem manufacturing site.(b)(4).Date of event: date of event is unknown.The date received by manufacturer has been used for this field.Initial reported address: (b)(6).Investigation summary: no samples (including photos) were returned for the reported issue of ¿leakage¿ with lot number 2029053 regarding item number 300844, so retention samples were used for the investigation.The investigation and simulation were carried out on ten retention samples where the investigating team has tested the samples for leakage and no leakage was found in the ten retention samples.Since no sample and no photographs were shared, the complaint was investigated based on the dhr result of lot no 2029053 for the sustaining and separation force tests done on this lot during release testing.The sustaining and separation forces were found to be within bd specifications.There is no defect found in the retention samples and in the dhr of the lot no.2029053.The defect could not be confirmed.No probable root cause could 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 leakage occurred while using bd discardit¿ ii syringes.100 syringes were affected, however, there was no patient impact reported.The following information was provided by the initial reporter: leakage while drawing blood.

• 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: 14959412
• MDR Text Key: 304540628
• Report Number: 2243072-2022-00918
• 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: 06/29/2022

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: 2029053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2022
• 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