MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW; PISTON SYRINGE

Model Number	305274
Medical Device Problem Codes	Leak/Splash (1354); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe integra 3ml w/ndl 21x1-1/2 rb tw detached from the needle after injection.The following information was provided by the initial reporter: a syringe has detached from the needle after injection.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-06-11.H.6.Investigation summary forty-three 3ml integra syringes in fully sealed blister packs from batch 8317519 (p/n 305274) were received and evaluated.All the syringes were visually inspected with no defects observed.On each of the syringes the plunger rod was depressed, and the retraction mechanism was activated.On each of the samples the mechanism appeared to function as expected with the cannula becoming concealed inside the plunger rod.Please note that integra syringes are equipped with a needle retraction mechanism.Based on the samples provided, it appeared the retraction mechanism functioned as expected and the cannulas were concealed inside the plunger rod.The integra ifu has been attached to provide instructions for use and a description of device's designed function.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.
Event or Problem Description
It was reported that syringe integra 3ml w/ndl 21x1-1/2 rb tw detached from the needle after injection.The following information was provided by the initial reporter: a syringe has detached from the needle after injection.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 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: 10131058
• Report Number: 1213809-2020-00379
• Device Sequence Number: 3184186
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: 30382903052746
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 305274
• Device Catalogue Number: 305274
• Device Lot Number: 8317519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 07/05/2020
• 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