MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number 301947

Device Problems Loose or Intermittent Connection (1371); Packaging Problem (3007)

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

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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¿ syringe with needle stopper was loose and had a poor seal during use.The following information was provided by the initial reporter, translated from chinese: "when the disposable sterile syringe was unpacked and ready for use, routine inspection revealed air leakage and poor sealing, making it impossible to draw medicine.".

Manufacturer Narrative

The initial mdr reflects the incorrect as reported code.

Event Description

No new pertinent information to report.

Manufacturer Narrative

A device history record review was completed for provided material number 301947 and lot number 2108194.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty (20) retained samples were obtained from the manufacturing facility.The retained samples were evaluated; however, no defects were identified.Based on the investigation results, an exact cause could not be determined for this incident.It is possible that the reported issue resulted from damage to the plunger component.This type of damage may be produced during the handling of the product through the manufacturing process or within the plunger assembly machine; however, the exact cause cannot be determined at this time.Per the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

No additional information.

• Brand Name: BD¿ SYRINGE WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17926603
• MDR Text Key: 325569192
• Report Number: 3002682307-2023-00307
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2024

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: 301947
• Device Lot Number: 2108194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/30/2023; 01/23/2024
• Supplement Dates FDA Received: 11/28/2023; 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• 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