MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT II 10 ML SYRINGE

Catalog Number 309110

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a device history record review was completed for provided lot number 2104112.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 of the same lot number were obtained from the manufacturing facility for examination.The retained samples did not reveal any signs of defect.Per the provided feedback, it is possible the reported leakage was a result of damage to the plunger lip component.This type of damage can be produced during the handling of the product through the manufacturing facility or within the plunger assembly machine.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.A quality process has been opened with the aim of reducing the recurrence of this type of damage.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.Investigation conclusion: based on the customer feedback of the issue, we conclude that the cause of the problem could be produced as a consequence of a damage in the plunger lip, that damage caused the reported leak issue.This damage could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.

Event Description

It was reported that the bd discardit¿ ii 10 ml syringe experienced leakage.The following information was provided by the initial reporter: syringe leaks: air leakage through the plunger + product flow through the syringe.Consequences: none because the syringe was discarded and the product reconstituted with another syringe.I think it was while preparing an antibiotic.I couldn't tell you which one in detail.But the problem is not really the product in question, but rather the quality of the syringe.It's not the first time this has happened to me and i think i've had leaks with nacl alone.There was no impact on the patient because i changed the syringe.

• Brand Name: BD DISCARDIT II 10 ML SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12277988
• MDR Text Key: 265152241
• Report Number: 3002682307-2021-00384
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309110
• Device Lot Number: 2104112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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