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

Model Number	305273
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10237811
• Report Number: 1213809-2020-00443
• Device Sequence Number: 596727
• Product Code: MEG
• UDI-Device Identifier: 30382903052739
• UDI-Public: 30382903052739
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other