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

Catalog Number 305270

Device Problems Fail-Safe Design Failure (1222); Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown.No lot # provided.Device manufacture date: unknown.Investigation: investigation summary: dhr review cannot be performed due to lot # not having been provided.No samples (including photos) were returned therefore the complaint could not be confirmed and root cause is undetermined.Based on no sample/ no photo, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failure.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.Investigation conclusion: no samples (including photos) were returned therefore the complaint could not be confirmed and root cause is undetermined.Root cause description: no samples (including photos) were returned therefore the complaint could not be confirmed and root cause is undetermined.

Event Description

It was reported that a bd integra¿ 3ml syringe with detachable needle malfunctioned after use as the safety device failed.A pharmacist stuck herself after the needle did not retract back into the hub after pressing the end button.It is unknown what type of medical intervention was given.

• Brand Name: BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7028413
• MDR Text Key: 91926561
• Report Number: 1213809-2017-00267
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: 30382903052708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Pharmacist
• Device Catalogue Number: 305270
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2017
• 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
• Patient Outcome(s): Other