MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BS SYRINGE ORAL 3ML CLEAR

Catalog Number 305220

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

It was reported that the bs syringe oral 3ml clear contained mixed product/lots.The following information was provided by the initial reporter: po number, whs, item number, ordered quantity, discrepancy quantity, uom, reason, expiration date, lot number, warehouse, comments, supplier comments.(b)(4), il1, 58305220, (b)(4), 400, ea concealed damage, different item inside case, item inside 58305219.Addition information provided on 23jan2024: "item 305220 was received in full (1 case) once the warehouse opened this up, they realized inside the case was actually item 305219.The warehouse stated that they had 400 each there were incorrect and those were disposed of after no response.".

Manufacturer Narrative

B.3.The date received by manufacturer has been used for this field.E.1.Address was not located and il was used.No photos or physical samples of the bs syringe oral 3ml clear product code # 305220, with the reported issue of ¿mixed product / lots ¿, were available for investigation.Product undergoes inspections throughout the manufacturing process according to procedure.As the lot involved in this incident is unknown, a device history review cannot be performed.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.

Manufacturer Narrative

Pr 9249460 follow-up report for correction.The date received from manufacturer was incorrect in the initial mdr.Customer provided confirmation on 22jan2024 that the complaint was the result of "mixed product/lots".

Event Description

No additional information provided.

• Brand Name: BS SYRINGE ORAL 3ML CLEAR
• Type of Device: 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: 18594860
• MDR Text Key: 335082737
• Report Number: 1213809-2024-00037
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305220
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1