MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE SFTYGLD 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 305916

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that leakage occurred during use with a needle sftygld 25x1 rb.The following information was provided by the initial reporter, "writer immunized client with the dtap vaccine, the fluid leaked between the needle hub and the syringe upon injection.Immunization not effective.Writer assessed the connection between the needle and syringe, and noted the needle hub was slightly warped.Not expired- cannot recall exact expiry date.".

Manufacturer Narrative

H.6 investigation summary : since no samples displaying the reported condition were received a potential root cause could not be defined.At this time, no corrective actions are necessary.Complaints received for this device and reported condition will continue to be tracked and trended.A dhr was performed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 6055988 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that leakage occurred during use with a needle sftygld 25x1 rb.The following information was provided by the initial reporter, "writer immunized client with the dtap vaccine, the fluid leaked between the needle hub and the syringe upon injection.Immunization not effective.Writer assessed the connection between the needle and syringe, and noted the needle hub was slightly warped.Not expired- cannot recall exact expiry date.".

• Brand Name: NEEDLE SFTYGLD 25X1 RB
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9908152
• MDR Text Key: 198958038
• Report Number: 1213809-2020-00224
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903059165
• UDI-Public: 30382903059165
• Combination Product (y/n): N
• PMA/PMN Number: K951254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Model Number: 305916
• Device Catalogue Number: 305916
• Device Lot Number: 6055988
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other