MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD TUBERCULIN SYRINGE WITH THE BD PRECISIONGLIDE DETACHABLE NEEDLE; PISTON SYRINGE

Model Number 309623

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: 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.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd precisionglide¿ detachable needle of the bd¿ tuberculin syringe had pierced through the shield/cap before use.The following information was provided by the initial reporter: "the needle was bent on purpose for injecting the solvent.  this resulted with an injury:  a hypodermic needle was capped on my mayo stand and when i went to pick it up, i got stuck by the point of the needle because it had gone through the cap.".

• Brand Name: BD TUBERCULIN SYRINGE WITH THE BD PRECISIONGLIDE DETACHABLE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12215151
• MDR Text Key: 266447402
• Report Number: 1213809-2021-00515
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096238
• UDI-Public: 30382903096238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 309623
• Device Catalogue Number: 309623
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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