MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP

Catalog Number 302995

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 09/10/2018

Event Type  Injury  

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 with the use of the bd syringe luer-lok¿ tip there was an issue with a cracked barrel.During an emergency case, the medication sprayed out of the crack onto the nurse and patient.It was reported that another dose of the rapid treatment medication was needing to be drawn up urgently.

Manufacturer Narrative

Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.No root cause can be determined as no samples were received.

Event Description

It was reported with the use of the bd syringe luer-lok tip there was an issue with a cracked barrel.During an emergency case, the medication sprayed out of the crack onto the nurse and patient.It was reported that another dose of the rapid treatment medication was needing to be drawn up urgently.

• Brand Name: BD SYRINGE LUER-LOK¿ TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7926786
• MDR Text Key: 122370973
• Report Number: 1213809-2018-00644
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903029953
• UDI-Public: 30382903029953
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 302995
• Device Lot Number: 8158776
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other