• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA; PISTON SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA; PISTON SYRINGE Back to Search Results
Catalog Number 305270
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2023
Event Type  malfunction  
Event Description
It was reported that the bd integra syringe had a needle retraction failure.The following information was provided by the initial reporter: "im injection given to client with 3 ml bd integra 25g retractable syringe, after administration the the needle tip flew off while retracting the syringe.This is the second needle same lot number at our facility that this happened with." verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2023.Type of incident/problem: malfunction - during or after use.Level of harm: no apparent harm - reached patient/person.Ahs optional report to cmdsnet (health canada): yes.Incident details: im injection given to client with 3 ml bd integra 25g retractable syringe, after administration the needle tip flew off while retracting the syringe.This is the second needle same lot number at our facility that this happened with.Manufacturer code/model: 305270.Serial or lot number: (b)(6).Expiry date: 2026-09-30.
 
Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
 
Manufacturer Narrative
One photo of a 25x1" integra needle was received for evaluated.The image shows a loose needle on the floor with the cannula attached to the hub.The reported defect cannot be confirmed from the photo provided.The condition observed is acceptable per product specification.It is recommended to hand-tighten the needle to the syringe prior to use.The reported defect was not identified in the samples received.Therefore, no corrective action is required currently.Lot 1302455 is considered in compliance with our product specification requirements.It is recommended to hand-tighten the needle to the syringe prior to use.A device history record review was completed for provided lot number 1302455 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
 
Event Description
Material#: 305270, lot#: 1302455.It was reported by the customer that the after administration the needle tip flew off while retracting the syringe.Verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(6).Date of incident (yyyy-mm-dd): 2023-12-17.Type of incident/problem: malfunction - during or after use level of harm: no apparent harm - reached patient/person ahs optional report to cmdsnet (health canada): yes.Incident details: im injection given to client with 3 ml bd integra 25g retractable syringe, after administration the needle tip flew off while retracting the syringe.This is the second needle same lot number at our.Facility that this happened with.Manufacturer code/model: 305270 serial or lot number: 1302455.Expiry date: 2026-09-30.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD INTEGRA
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
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18496708
MDR Text Key333017910
Report Number1213809-2024-00003
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903052708
UDI-Public(01)30382903052708
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K011103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/02/2024
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
Device Operator Other
Device Catalogue Number305270
Device Lot Number1302455
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/11/2024
Supplement Dates Manufacturer Received07/02/2024
Supplement Dates FDA Received07/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
-
-