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

Catalog Number 309657

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip was cracked and "sprayed" lidocaine out of the sides and onto the doctor, the assistant, and the patient during use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: on three separate occasions, the doctor encountered bd 3ml syringes that were cracked.When administering lidocaine during biopsies, the lidocaine sprayed out of the side of the syringes onto the doctor, his assistant, and the patient.

Manufacturer Narrative

H.6.Investigation: 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 could not be performed as lot number was unknown.

Event Description

It was reported that the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip was cracked and "sprayed" lidocaine out of the sides and onto the doctor, the assistant, and the patient during use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: on three separate occasions, the doctor encountered bd 3ml syringes that were cracked.When administering lidocaine during biopsies, the lidocaine sprayed out of the side of the syringes onto the doctor, his assistant, and the patient.

• Brand Name: BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9104151
• MDR Text Key: 175838565
• Report Number: 2243072-2019-02083
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309657
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other