MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML LL BNS; PISTON SYRINGE

Catalog Number 301027

Device Problem Missing Information (4053)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that the bd syringe 5ml ll bns label content was missing.The following information was provided by the initial reporter: "1 ca of pcn 301027 is missing labels, so the customer cannot use the product.".

Event Description

No additional information.

Manufacturer Narrative

(b)(4): follow up mdr for device evaluation.Three photos of an export box were received and evaluated.Two of the images each shows a short side of the export box with no box number written or label affixed on the box.The other image shows a piece of paper with the material and batch numbers handwritten.The condition observed is non-conforming per product specification.Potential root cause for the missing label defect is associated with the bulk handling process.The reported defect was manufactured in the holdrege plant which no longer manufactures this product.Therefore, no corrective actions are required from the canaan manufacturing plant.A device history record review was completed for provided lot number 2300963 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SYRINGE 5ML 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18027116
• MDR Text Key: 327763200
• Report Number: 1213809-2023-01193
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 50382903010276
• UDI-Public: (01)50382903010276
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301027
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1