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

Catalog Number 305270

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2023

Event Type  malfunction  

Event Description

It was reported that the bd integra needle retraction failed.The following information was provided by the initial reporter: " writer went to give client im dimenhydrinate, writer administered same with retractable 25g im syringe.Writer pushed plunger in to retract needle and needle tip came flying out and almost hit staff cca." ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2023.Site name/location: (b)(6).Level of harm: no apparent harm - reached patient/person, inconvenient incident details: writer went to give client im dimenhydrinate, writer administered same with retractable 25g im syringe.Writer pushed plunger in to retract needle and needle tip came flying out and almost hit staff cca.Impact of incident: no concern to patient she had received her dose.Close call for staff.Who was affected? patient.Device name/description: syringe 3ml with detachable integra needle 25 gauge x 1 inch.Manufacturer: becton dickinson canada inc.Manufacturer code/model: 305270.Serial or lot number: (b)(6).Device expiry date (yyyy-mm-dd): unknown.Supplier: (b)(4).Supplier catalogue number: 308-305270.Was the device retained? no.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

Pr 9440935 ¿ follow up mdr for device evaluation since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were 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.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.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.H3 other text : see h10 manufacture narrative.

Event Description

No additional information.

• 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 Key: 18508585
• MDR Text Key: 333245914
• Report Number: 1213809-2023-01536
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: (01)30382903052708
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305270
• Device Lot Number: 1302455
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1