MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE

Catalog Number 309628

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

The customer's address is unknown.(b)(6) has been used as a default.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 bd luer-lok¿ tip syringe plunger was loose and wouldn't hold it's place while preparing the dose of eylea.The following information was provided by the initial reporter: "on (b)(6) 2022, the reporter contacted.Information requesting replacement for one eylea vial.She stated that when the physician was priming the medication and tried to push up on the plunger, the plunger would not hold its place.The plunger did not fall out but rather it wouldn't hold its place.Vial difficulty preparing the dose.".

Manufacturer Narrative

H6: investigation summary: no samples received by our quality team for evaluation.According to verbatim, the complaint appears to be for the absence of retaining ring in the syringe barrel.This product does not have a retaining ring by design according to its product specification.Since the reported condition is likely related to the product design and the photos received did not indicate any defects a potential root cause could not be established.The reported condition is related to product design and not a true defect.Therefore, a dhr review is not required.

Event Description

It was reported that the bd luer-lok¿ tip syringe plunger was loose and wouldn't hold it's place while preparing the dose of eylea.The following information was provided by the initial reporter: "on 14-nov-2022, the reporter contacted.Information requesting replacement for one eylea vial.She stated that when the physician was priming the medication and tried to push up on the plunger, the plunger would not hold its place.The plunger did not fall out but rather it wouldn't hold its place.Vial difficulty preparing the dose".

• Brand Name: BD LUER-LOK¿ TIP 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 ; 8015296192
• MDR Report Key: 16238253
• MDR Text Key: 308710561
• Report Number: 1213809-2023-00030
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: 00382903096282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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 Expiration Date: 04/30/2024
• Device Catalogue Number: 309628
• Device Lot Number: 9142579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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