MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE; PISTON SYRINGE

Catalog Number 309646

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 the plunger fell out of the bd luer-lok¿ sterile, single use syringe while transferring medicine, leaking medication onto the floor as a result.The following information was provided by the initial reporter: "this was the issue reported: material seems to be not as good as it used to be, for example yesterday we had a doctor transferring medicine in to one of this syringes and the plunger of the syringes came off and the medicine felt on the floor.".

Event Description

It was reported that the plunger fell out of the bd luer-lok¿ sterile, single use syringe while transferring medicine, leaking medication onto the floor as a result.The following information was provided by the initial reporter: "this was the issue reported: material seems to be not as good as it used to be, for example yesterday we had a doctor transferring medicine in to one of this syringes and the plunger of the syringes came off and the medicine felt on the floor.".

Manufacturer Narrative

H6: 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.

• Brand Name: BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE
• 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 ; 8448235433
• MDR Report Key: 16574270
• MDR Text Key: 312019339
• Report Number: 1213809-2023-00225
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096466
• UDI-Public: 00382903096466
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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: 309646
• Device Lot Number: 2088051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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