MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK TIP DISPOSABLE SYRINGE; PISTON SYRINGE

Model Number 309657

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/11/2021

Event Type  malfunction  

Manufacturer Narrative

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 luer-lok¿ tip disposable syringe leaked insulin while depressing the plunger.The following information was provided by the initial reporter: "in the process of loading a cartridge while depressing the plunger on the syringe insulin leaked out, possibly due a manufacturing defect".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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.H3 other text : see h.10.

Event Description

It was reported that the bd luer-lok¿ tip disposable syringe leaked insulin while depressing the plunger.The following information was provided by the initial reporter: "in the process of loading a cartridge while depressing the plunger on the syringe insulin leaked out, possibly due a manufacturing defect.".

• Brand Name: BD LUER-LOK TIP DISPOSABLE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 12295661
• MDR Text Key: 265658035
• Report Number: 9614033-2021-00089
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 309657
• Device Catalogue Number: 309657
• Device Lot Number: 0044630
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR