MAUDE Adverse Event Report: BD 10ML SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE

Catalog Number 301029

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.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 bd 10ml syringe luer-lok¿ tip experienced a mix of product types in a pack.The following information was provided by the initial reporter: 5cc ((b)(4)) syringes were mixed up with the 10cc ((b)(4)) syringes.

Event Description

It was reported that the bd 10ml syringe luer-lok¿ tip experienced a mix of product types in a pack.The following information was provided by the initial reporter: 5cc (200022867) syringes were mixed up with the 10cc (300042939) syringes.

Manufacturer Narrative

H6: investigation summary: the 10ml product in question runs on a dedicated 10ml line.Unmarked barrels have scale printed, then marked barrels are assembled with 10ml plungers and stoppers.The setup of the line is such that 5ml barrels (marked or unmarked) would not be able to run through the marker.If by chance marked barrels were to bypass the marker and be introduced at assembly, the assembly with stopper plunger would not be physically possible due to different size of components.Machine would likely destroy components and jam.The bulk packaging is directly connected to the assembly machine¿s output via automated conveyor system.There are no 5ml machines in the vicinity of this dedicated 10ml line for accidental part swap or finished syringe product to occur.Potential root cause for the mixed product defect could not be linked to the syringe manufacturing process.Based on the information available today, it is highly unlikely for the 5ml syringe to have been mixed with 10ml ll bulk syringe product shipped to customer.The manufacturing line is not designed for any product other than 10ml syringes, and it would not be possible to run any other size.Since the reported defect was not confirmed to originate at the syringe manufacturing plant, corrective actions are not necessary.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD 10ML SYRINGE LUER-LOK¿ TIP
• Type of Device: PISTON SYRINGE
• MDR Report Key: 12537381
• MDR Text Key: 273583544
• Report Number: 1213809-2021-00671
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301029
• Device Lot Number: 1005805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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