MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD INTEGRA¿ RETRACTING SAFETY SYRINGE; ANTI-STICK SYRINGE

Model Number 305270

Device Problem Leak/Splash (1354)

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

Event Date 01/23/2022

Event Type  malfunction  

Event Description

It was reported while using 3 ml bd integra¿ retracting safety syringe leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: material no: 305270 batch no: 1004209   it was reported by the consumer the medication leaked from around the hub on two syringes.  date of event: (b)(6) 2022.

Manufacturer Narrative

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

Manufacturer Narrative

H.6.Investigation: two loose 3ml integra syringes with needle (p/n 305270) were received and evaluated.No visual defects were observed around the luer collar or its threading on each syringe.The samples were tested for leakage at the luer connection per procedure, no leakage was observed during testing.A small amount of missing print was noted on the 2.5ml numeral on one of the syringes.It is unclear if this occurred during syringe handling or manufacturing defect.The syringes received were acceptable per product specification.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.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 3 ml bd integra¿ retracting safety syringe leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: material no: 305270.Batch no: 1004209.  it was reported by the consumer the medication leaked from around the hub on two syringes.  date of event: (b)(6) 2022.

• Brand Name: 3 ML BD INTEGRA¿ RETRACTING SAFETY SYRINGE
• Type of Device: ANTI-STICK 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: 13471716
• MDR Text Key: 285714948
• Report Number: 1213809-2022-00049
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: 30382903052708
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 305270
• Device Catalogue Number: 305270
• Device Lot Number: 1004209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2021
• 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
• Patient Sex: Female