MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT II SYRINGE

Catalog Number 300844

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2019

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.(b)(6).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 that bd discard it ii¿ syringe came with mixed products.No serious injury or medical intervention was reported.

Event Description

It was reported that bd discardit ii¿ syringe came with mixed products in 30 cartons.No serious injury or medical intervention was reported.

Manufacturer Narrative

It was reported that bd discardit ii¿ syringe came with mixed products in 30 cartons.No serious injury or medical intervention was reported.Investigation: dhr was conducted for both affected lot# 18c031, found no non-conformities.As no picture or device was sent back the complaint could not be confirmed.The team reviewed the packaging process and confirmed that the process control related to packaging operation are in place and being followed.During the manufacturing of lot, line clearance was performed and the variable printing information on unit, shelf & case pack were verified.There was no such occurrence or deviation of any process in plant which could lead to product mix as claimed by the customer.Also, during the in process quality check no defect was observed related to product mix.Bawal plant associate had visited the customer site for this complaint.The customer had shared the invoice which suggests that 53.7 & 49.3 shippers were dispatched for lot numbers 18d1211 & 18c0311 respectively.All together 103 shippers were sent under this invoice, that means 0.7 & 0.3 shippers of both the lots were loose shippers.The associate in distribution center had mistakenly put the loose quantities (0.7& 0.3) in a single shipper and made it complete instead of sending both the shippers in different shipper.This shipper got dispatched to customer.The customer had claimed this shipper as mix product.

• Brand Name: BD DISCARDIT II SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8260740
• MDR Text Key: 133750891
• Report Number: 2243072-2019-00004
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 300844
• Device Lot Number: 18C0311
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other