MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD ORAL SYRINGE; CONTAINER, LIQUID MEDICATION, GRADUATED

Catalog Number	305207
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd oral syringe had a scale marking issue.The following information was provided by the intial reporter translated from french to english: "the customer declares a quality defect on syringes ref 305207 / the graduations fade when touched / the order and invoice date from 2019.".
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
One sample and one photo of a 1ml amber oral syringe (p/n ¿ 305207) were received and evaluated.The syringe received loose is missing almost all the scale markings on the barrel.The photo shows one loose syringe with the missing scale markings as described above.The condition observed is non-conforming per product specification.Potential root cause for the scale markings missing defect is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.A device history record review was completed for provided lot number 8324968 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 ORAL SYRINGE
• Common Device Name: CONTAINER, LIQUID MEDICATION, GRADUATED
• 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: 19582109
• Report Number: 1213809-2024-00401
• Device Sequence Number: 12594192
• Product Code: KYW
• UDI-Device Identifier: 50382903052078
• UDI-Public: (01)50382903052078(11)181120(10)8324968
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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
• Operator of Device: Other
• Device Catalogue Number: 305207
• Device Lot Number: 8324968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown