MAUDE Adverse Event Report: BECTON DICKINSON BD PLASTIPAK SYRINGE WITH NEEDLE

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/27/2024

Event Type  Injury  

Event Description

A needle stick injury was reported with the bd plastipak syringe with needle.The following information was provided by the initial reporter translated from portuguese to english: "employee victim of accident at work with sharps (probe? glass?) with contact with biological material (unknown source).Carried out tests and rapid tests with negative results, advised to go to her local psf to continue treatment and new tests.".

Manufacturer Narrative

D.3.Franklin lakes has been listed as the manufacturer.As no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, the investigation could not be confirmed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.See narrative below.

• Brand Name: BD PLASTIPAK SYRINGE WITH NEEDLE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19042849
• MDR Text Key: 339435339
• Report Number: 2243072-2024-00500
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other