MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 25X1 RB; PISTON SYRINGE

Catalog Number 305270

Device Problem Leak/Splash (1354)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe integra 3ml w/ndl 25x1 rb leaked.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that vaccine is leaking out of the syringe down her customers arm as she is giving the shot.

Manufacturer Narrative

Investigation summary: 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.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.H3 other text : see h10.

Event Description

It was reported that syringe integra 3ml w/ndl 25x1 rb leaked.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that vaccine is leaking out of the syringe down her customers arm as she is giving the shot.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 25X1 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12543356
• MDR Text Key: 273767080
• Report Number: 1213809-2021-00673
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382903052707
• UDI-Public: 00382903052707
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

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 Number: 305270
• Device Lot Number: 0266457
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1