MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3 ML LL BNS; PISTON SYRINGE

Catalog Number 301073

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/03/2023

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 1600 of the bd syringe 3 ml ll bns were missing the label information.The following information was provided by the initial reporter, translated from japanese to english: label on box missing for product.

Event Description

It was reported that 1600 of the bd syringe 3 ml ll bns were missing the label information.The following information was provided by the initial reporter, translated from japanese to english: label on box missing for product.

Manufacturer Narrative

H6: investigation summary one photo was provided to our quality team for investigation.Upon examination of the returned photo, it was observed that a bulk-nonsterile box with the number ¿136¿ written on it with marker.The box was missing any type of identification beyond the box number and was non-conforming per product specification.Potential root cause for the missing box label defect is associated with a failure to properly follow the label verification process.A device history record review was completed for provided lot number 2279614.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h10.

• Brand Name: BD SYRINGE 3 ML LL BNS
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16792350
• MDR Text Key: 313828647
• Report Number: 1213809-2023-00392
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301073
• Device Lot Number: 2279614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1