MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ LUER-SLIP SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number 302131

Device Problems Partial Blockage (1065); Leak/Splash (1354)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

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-slip syringe with needle plunger was difficult to move and medicine leaked from the hub connection.This occurred with 10 separate syringes during use.The following information was provided by the initial reporter: "the plunger doesn't easy to be pushed and pulled.Sometimes, medicine may leak out between hub and syringe during use".

Manufacturer Narrative

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-slip syringe with needle plunger was difficult to move and medicine leaked from the hub connection.This occurred with 10 separate syringes during use.The following information was provided by the initial reporter: "the plunger doesn't easy to be pushed and pulled.Sometimes, medicine may leak out between hub and syringe during use".

Event Description

It was reported that the bd¿ luer-slip syringe with needle plunger was difficult to move and medicine leaked from the hub connection.This occurred with 10 separate syringes during use.The following information was provided by the initial reporter: "the plunger doesn't easy to be pushed and pulled.Sometimes, medicine may leak out between hub and syringe during use.".

Manufacturer Narrative

H.6.Investigation: eleven samples were received by our quality team for evaluation.One sample was received in open packaging without the syringe barrel and ten representative samples were received in sealed packaging.The representative samples were subjected to plunger breakout and sustaining force testing and the leak test.The samples passed the testing.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD¿ LUER-SLIP SYRINGE WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13167992
• MDR Text Key: 285564266
• Report Number: 8041187-2021-01091
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302131
• Device Lot Number: 1049226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• 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