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

Catalog Number 309210

Device Problem Break (1069)

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

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the tip/luer of the bd discardit¿ ii syringe had broken off and was missing.The following information was provided by the initial reporter: "cone of the syringe was missing.".

Event Description

It was reported that the tip/luer of the bd discardit¿ ii syringe had broken off and was missing.The following information was provided by the initial reporter: "cone of the syringe was missing,".

Manufacturer Narrative

H6: investigation summary a device history record review was completed for provided material number 309210 and lot number 2031729.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty retained samples were obtained for evaluation; however, no signs of defect were found.Although we were unable to confirm the reported incident for this record specifically, this type of defect has been previously confirmed for this lot number based on previous samples received.The material used to manufacture the discardit syringes has been selected and tested to resist normal conditions of use.The assembly machines have an inline detection system which inspects all product and automatically rejects any damaged product identified.This incident most likely resulted from a blockage during the barrel feeding process.After the blockage, the tip of the syringe was damaged and went undetected within the assembly machine.

• Brand Name: BD DISCARDIT¿ II SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16075258
• MDR Text Key: 308481124
• Report Number: 3002682307-2022-00354
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309210
• Device Lot Number: 2031729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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