MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD 1ML SYRINGE

Catalog Number 305839

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

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as neither a lot number nor a sample was available for this incident, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that bd 1ml syringe experienced 3 cases of loose needles, 4 cases of leakage, and 5 cases of scale marking issues.The following information was provided by the initial reporter, translated from french to english: non-precise grading, brutality of the injection, needle too big or wrong bevel.Impossible volume precision.Piston leaks from syringe body.Difficult reading of the graduation.Error when reading, leakage.Difficult to read the graduations.Graduation very complicated to read during the preparation.Graduation difficult to read.Painful injection.Poor visibility graduation.Accuracy of graduation insufficient to adjust volume.Difficult to read the sampled volume.This syringe seems inaccurate.The security of an exact dose is not assured.The reading is very difficult, the measurement does not seem precise.The graduations are not very precise because only graduated from 0,1 to 0,1.

• Brand Name: BD 1ML SYRINGE
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12756134
• MDR Text Key: 284989957
• Report Number: 3002682307-2021-00593
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305839
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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