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

Model Number 309628

Device Problems Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The customer's address is unknown. Unknown, new jersey, 00000 usa 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 flanges on the bd luer-lok¿ tip syringe were bent and damaged, and the scale markings were off "by a centimeter or so". The following information was provided by the initial reporter: "they said the scale marking appeared to be shifted and ¿bent¿ flanges. The observation appears to have been made at point of use. " "the reporter stated the barrel flange or finger flange got overheated and was bent. The syringe was fully intact but seems like during the making of the syringe, it got bent. For the same syringe, the volume markings on the end of the syringe is incorrect. The markings were off by a centimeter or so. Therefore, the amount of medication delivered would be incorrect. The eylea vial was used but another bd syringe was used instead. ".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12439333
• MDR Text Key: 270309350
• Report Number: 1213809-2021-00620
• Device Sequence Number: 1
• Product Code: FMF
• 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: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 9051805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial