MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 23X1 RB; PISTON SYRINGE

Model Number 305271

Device Problems Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

Event Type  Injury  

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 Description

It was reported that syringe integra 3 ml w/ ndl 23 x 1 rb retracted during injection.The following information was provided by the initial reporter: material no: 305271, batch no: 8092761.It was reported that the consumer found when injecting that the needle retracted.Verbatim: consumer reported found when injecting, the needle retracted.Noted this was the first time retracting when injecting.Thought the needle broke in his site.Went to the hospital.They completed xrays and informed him to call bd.They did not provide results of x ray.When i spoke with him i informed it was a retracting needle and how the product worked.He removed the needle hub and found the needle and spring.Was happy to find the needle and satisfied.

Manufacturer Narrative

The following fields have been updated with corrections: b.2.Event attributed to: required intervention.B.6.Relevant tests/laboratory data: consumer went to the hospital and received xrays.F.10.Device codes: 2993.H.1.Type of reportable events: serious injury.

Event Description

It was reported that syringe integra 3ml w/ndl 23x1 rb retracted during injection.The following information was provided by the initial reporter: material no: 305271, batch no: 8092761.It was reported that the consumer found when injecting that the needle retracted.Verbatim: consumer reported found when injecting, the needle retracted.Noted this was the first time retracting when injecting.Thought the needle broke in his site.Went to the hospital.They completed xrays and informed him to call bd.They did not provide results of x ray.When i spoke with him i informed it was a retracting needle and how the product worked.He removed the needle hub and found the needle and spring.Was happy to find the needle and satisfied.

Manufacturer Narrative

H.6.Investigation: no photos or samples were received for evaluation.Based on the verbatim, it appears the device functioned as expected.The reported defect was unfortunately not identified.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.

Event Description

It was reported that syringe integra 3ml w/ndl 23x1 rb retracted during injection.The following information was provided by the initial reporter: material no: (b)(6) batch no: 8092761 it was reported that the consumer found when injecting that the needle retracted.Verbatim: consumer reported found when injecting, the needle retracted.Noted this was the first time retracting when injecting.Thought the needle broke in his site.Went to the hospital.They completed xrays and informed him to call bd.They did not provide results of x ray.When i spoke with him i informed it was a retracting needle and how the product worked.He removed the needle hub and found the needle and spring.Was happy to find the needle and satisfied.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 23X1 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10411647
• MDR Text Key: 205507191
• Report Number: 1213809-2020-00533
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: 30382903052715
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 305271
• Device Catalogue Number: 305271
• Device Lot Number: 8092761
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention