MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 21X1 RB TW; PISTON SYRINGE

Model Number 305273

Device Problem Difficult or Delayed Activation (2577)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

Investigation summary: ten 3ml integra syringes in fully sealed blister packs from batch 8095530 (p/n 305273) were received and evaluated.The plunger rods were aspirated on all the samples and a visual inspection was performed with no defects observed on any of the syringes.The plunger rods were then depressed, and the retraction mechanism functioned as expected with the cannula being concealed inside the plunger rod.The reported defect was not identified in the samples received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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.(b)(4).

Event Description

It was reported that the syringe integra 3ml w/ndl 21x1 rb tw experienced needle retraction failure and was involved with a sirty needle stick injury.It has been mentioned that the nurse who received the dirty needle stick injury received medical intervention as a result, though the specific intervention or any associated testing results have not been specified.The following information was provided by the initial reporter: material no: 305273, batch no: 8095530.Customer called to report that needle did not retract causing the nurse to get stuck with the needle after injection.She stated that the nurse was sent out per protocol to medical facility, it happened last night and employee health was not open at that time.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 21X1 RB TW
• 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: 10237811
• MDR Text Key: 199752264
• Report Number: 1213809-2020-00443
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052739
• UDI-Public: 30382903052739
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 305273
• Device Catalogue Number: 305273
• Device Lot Number: 8095530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2018
• 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