MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 1ML LS 25GA 5/8IN

Catalog Number 300841

Device Problems Leak/Splash (1354); Material Separation (1562)

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

Event Date 02/10/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd syringe 1ml ls 25ga 5/8in stopper separation from plunger the following information was provided by the initial reporter; the syringe piston and piston shaft are disconnected, and the piston cannot be driven by pulling the piston handle.It was discovered during dispensing that the syringe was replaced promptly and no consequences were caused to the patient.

Manufacturer Narrative

No photo/sample was received for further investigation.Root cause could not be determined.Review of the dhr showed that no abnormality was observed during production run of this reported batch.Current control there is a daily qa routine breakout and sustaining forces test.The complaint will be re-opened and re-investigated when sample is received.H3 other text : see h10 manufacture narrative.

Event Description

The syringe piston and piston shaft are disconnected, and the piston cannot be driven by pulling the piston handle.It was discovered during dispensing that the syringe was replaced promptly and no consequences were caused to the patient.

• Brand Name: BD SYRINGE 1ML LS 25GA 5/8IN
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18277096
• MDR Text Key: 330674960
• Report Number: 2243072-2023-02146
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300841
• Device Lot Number: 1265127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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