MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Model Number 305269

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or samples were received for evaluation.Unfortunately,since no samples displaying the reported condition were received a potential root cause could not be defined and no corrective actions are necessary at this time.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¿ 3 ml syringe with detachable needle experienced a needle that was loose/pulled out of hub during use.The following information was provided by the initial reporter: material no.: 305269, batch no.: unknown.Complaint 2 of 3.Customer called and stated that they had 3 separate instances with this product, but she only has the lot for 1, and is not sure if the other needles were part of the same lot.In the second instance, when the nurse tried to give the vaccine, the med would not push through.Per email: did the reported issues result in any serious injury, adverse event, change/delay in treatment, or medical intervention to prevent injury? in the second incident the needle dislodged from the syringe as the nurse was administering the vaccine, leaving the needle in the child's leg and spilling vaccine out of the syringe on to the child's leg.For the syringe that did not allow medication through, was the issue that the needle seemed clogged, plunger was difficult to move, or other issue? it seemed as if needle was blocked causing pressure to build up.When the medication spilled, was the medication hazardous and exposed to the skin of the patient or user? vaccines used were not hazardous to the skin.Are any of the affected devices available to be sent to bd for evaluation? i have two of the syringes from incidents.Are any patient identifiers available? no.

• Brand Name: BD INTEGRA 3 ML 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10103216
• MDR Text Key: 194344980
• Report Number: 1213809-2020-00343
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: 30382903052692
• 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: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305269
• Device Catalogue Number: 305269
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2020
• 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