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

Catalog Number 302995

Device Problem Crack (1135)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/10/2019

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 that the bd syringe luer-lok¿ tip filled with bupivacaine "sprayed the nurse practitioner in the eyes" during a lap chole due to a crack "along the length of the shaft".

Manufacturer Narrative

H.6.Investigation summary: 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.Furthermore, 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.

Event Description

It was reported that the bd syringe luer-lok¿ tip filled with bupivacaine "sprayed the nurse practitioner in the eyes" during a lap chole due to a crack "along the length of the shaft".

• Brand Name: BD SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8317992
• MDR Text Key: 135521057
• Report Number: 1213809-2019-00158
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 302995
• Device Lot Number: 8150882
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other