MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE

Catalog Number 309110

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd discardit¿ ii syringe was missing marking.No serious injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: our manufacturing site was provided with a photo of the product as well as the affected sample.Upon inspection, we could verify the scale marking was missing.We have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.A batch history review showed no non-conformances associated with this issue during the production of this batch.The process we use to print the scale is called "hot stamping system".A metal stamp is heated at around 100ºc.Between the stamp and the barrel, we place a special black printing foil.Using pressure, the stamp pushes the printing foil and its content is embedded in the barrel wall.The result is a black scale printed on the barrel of the syringe.It was determined this issue occurred at the end of this process as a result of a defective foil reel.The reel was not working properly and was not placed between the stamp and barrel, therefore the scale was not printed.Investigation conclusion: the foil reel did not work as expected and was not allocated between the stamp and the barrel, so no scale was printed.

Event Description

It was reported that bd discardit¿ ii syringe was missing marking.No serious injury or medical intervention reported.

Event Description

It was reported that bd discardit¿ ii syringe was missing marking.No serious injury or medical intervention reported.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.

• Brand Name: BD DISCARDIT¿ II SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7695628
• MDR Text Key: 114692026
• Report Number: 3002682307-2018-00172
• 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,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 309110
• Device Lot Number: 1804284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 06/25/2018; 06/25/2018
• Supplement Dates FDA Received: 08/20/2018; 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other