MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Catalog Number 305271

Device Problems Leak/Splash (1354); Retraction Problem (1536); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.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 integra¿ syringe with detachable needle leaked fluid down the patient's arm and was removed.However, when the button was pressed to retract the needle, part of the spring and plastic end "flew off" to the other side of the room.The following information was provided by the initial reporter: "administering im droperidol to patient using auto retractable syringe.While using, fluid leaked out of syringe and down pts arm, unknown how much was actually administered.Removed from pt before retracting due to obvious issue with item.On pressing button to retract needle, part of the item (spring and plastic end) flew off landing on the other side of the room.Managed to visualise needle inside syringe to confirm it had not also been launched across room.As per customer: it is likely that the needle was not checked and secured to the syringe when this incident occurred and we are currently putting it down to human error.".

• Brand Name: BD INTEGRA¿ SYRINGE WITH 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16542567
• MDR Text Key: 311311543
• Report Number: 1213809-2023-00200
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305271
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/14/2023
• 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