MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 10ML LL

Catalog Number 305959

Device Problems Fungus in Device Environment (2316); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 syringe 10 ml ll had foreign matter in the syringe.The following information was provided by the initial reporter: customer reported possible mould in syringe.The defect was noticed on (b)(6) 2020 during use.The person did notice it straight away while filling it with water for injection (about 0.8 ml) therefore i can confirm there are no medications in the syringe.

Manufacturer Narrative

H.6.Investigation summary: one sample and four photos were provided to our quality team for investigation.Upon visually inspecting the product, a small particle was observed on the stopper.Characterization analysis was performed in order to properly identify the composition of the particle.Testing results indicate the particle is composed of silicone and polypropylene.These particles generate during the movement of the product within the manufacturing equipment.A device history review was performed for lot 1909005, 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 uses a de-ionizer to remove any polypropylene particles inside the barrel.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.Based on the preventive measures in place and the current inspection process, this is believed to be an isolated issue with an unlikely recurrence.Complaints received for this device and reported issue will continue to be tracked and trended for future occurrence.

Event Description

It was reported that syringe 10ml ll had foreign matter in the syringe.The following information was provided by the initial reporter: customer reported possible mould in syringe.The defect was noticed on (b)(6) 2020 during use.The person did notice it straight away while filling it with water for injection (about 0.8ml) therefore i can confirm there are no medications in the syringe.

• Brand Name: SYRINGE 10ML LL
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9775399
• MDR Text Key: 211062597
• Report Number: 3003152976-2020-00091
• 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: 03/30/2020

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: 08/31/2024
• Device Catalogue Number: 305959
• Device Lot Number: 1909005
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other