MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN.; PISTON SYRINGE

Catalog Number 305271

Device Problem Defective Component (2292)

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

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.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.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.

Event Description

It was reported while using bd integra¿ 3 ml retracting safety syringe with 23 g x 1 in.The stopper was deformed.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported that the rubber stopper was slanted in the barrel, causing some of the medication to be left inside.

• Brand Name: BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN.
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15830479
• MDR Text Key: 307615595
• Report Number: 1213809-2022-01053
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382903052714
• UDI-Public: 00382903052714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/09/2022

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: 305271
• Device Lot Number: 0329608
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1