MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 60ML E/T; PISTON SYRINGE

Model Number 300866

Device Problem Fungus in Device Environment (2316)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one photo was provided to our quality team for investigation.Upon visually inspecting the photo, a brown particle was observed between the stopper and plunger.A device history review was performed for the reported lot 2006283, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.The assembly machine has a vacuum system to reduce any foreign particles within the syringe.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Without the actual sample to evaluate, we cannot verify the composition or origin of the particle, therefore a definitive root cause cannot be determined at this time.

Event Description

It was reported that a syringe 60ml e/t had mold presence before use.The following was reported by the initial reporter: "contaminant that looks like piece of fluff or mould found in sterile syringe.Noticed by operator and discarded before use.No harm caused.".

• Brand Name: SYRINGE 60ML E/T
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11925075
• MDR Text Key: 263419146
• Report Number: 3003152976-2021-00309
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903008668
• UDI-Public: 30382903008668
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: 2006283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• 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