MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML LL; PISTON SYRINGE

Model Number	305283
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.Medical device lot #: 8184681, medical device expiration date: 2023-06-30, device manufacture date: 2018-07-03.Medical device lot #: 8092763, medical device expiration date: 2023-03-31, device manufacture date: 2018-04-02.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 ll was damaged and leaked during use.The following information was provided by the initial reporter: during the intervention on friday, (b)(6) in an emergency, the syringe broke, with the minimum pushing of the pestle, the syringe broke and the medication poured out at the top.Then the system was also broken and the needle fell into the syringe.Annoying, because there was a lot of police on the move and the police and patient had to wait a long time.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-07-06.H.6.Investigation summary.Two photos and one loose 3ml integra syringe were received and evaluated.It appeared the syringe was manipulated as there was clear liquid in the fluid path and the retraction mechanism was activated as the metal cutter exposed through the stopper.It was observed the plunger rod was extended after the cannula was retracted as the spring and cannula were visible inside the syringe and not concealed inside the plunger rod.Please note the integra syringe has a needle retraction system that is activated by depressing the plunger rod to conceal the cannula inside.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 ll was damaged and leaked during use.The following information was provided by the initial reporter: during the intervention on friday, (b)(6) in an emergency, the syringe broke, with the minimum pushing of the pestle, the syringe broke and the medication poured out at the top.Then the system was also broken and the needle fell into the syringe.Annoying, because there was a lot of police on the move and the police and patient had to wait a long time.

• Brand Name: SYRINGE INTEGRA 3ML LL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10209504
• Report Number: 1213809-2020-00424
• Device Sequence Number: 19390200
• Product Code: MEG
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/08/2020

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 Model Number: 305283
• Device Catalogue Number: 305283
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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