MAUDE Adverse Event Report: BECTON DICKINSON DISCARDIT II 2 ML WITH 25G X 1; PISTON SYRINGE

Catalog Number 301866

Device Problem Packaging Problem (3007)

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

Event Date 06/25/2021

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 (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: 16 samples were received from the customer and were used for investigation of the reported defects.The investigating team also used the retention samples of material code 301866 and lot number 183969 for investigating the reported defect.The samples received for investigated have confirmed the defects reported by the customer.There are multiple defects reported in this complaint.The probable root cause for blister damage complaint.- worn out bush and difference in chain positions at in and out.Actions for blister damage complaints: all worn out bush to be replaced with new bush at bottom web loading station (30/sep/2020- completed.).Difference in both chain distance at in and out of m/c to be reduced to minimum difference (10/sep/2020- completed).Sprocket to open change clits at laminate feeding station to be replaced because they are worn out (20/sep/2020- completed).Static discharger to be fixed on flexi#1 machine after needle loader to eliminate static charge produced after needle loader (15/sep/2020- completed).Sensor to be provided at bottom web station to detect the roll diameter and adjust motor speed accordingly on flexi#1 (15/oct/2020- completed).Sensor to be provided at top web station to detect roll diameter and adjust motor speed accordingly on flexi#1 (10/apr/2021).Actions for foreign matter (black spot, hair, loose particle).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 13530 discardit ii 2 ml with 25g x 1 syringes leaked through the damaged blister packaging.This complaint was created to capture the 2nd of 4 related incidents.The following information was provided by the initial reporter: syringes received with foreign particles, black spot, hair particle, marketing defects, no needle, double needle , blister leakage, damaged syringe.

• Brand Name: DISCARDIT II 2 ML WITH 25G X 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12215726
• MDR Text Key: 266674417
• Report Number: 2243072-2021-01961
• 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: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2021

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: 301866
• Device Lot Number: 0183969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• 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