MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE ORAL 1ML AMBER; CONTAINER, LIQUID MEDICATION, GRADUATED

Catalog Number	305207
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.Investigation summary: it was reported that: ¿gtin / udi packaging information incorrect in gudid for (b)(4) (bd 305207)¿.Material 305207 consists of 500 non-sterile syringes packaged in 5 polybags containing (b)(4) each.Material 305207 gudid record reflects the current label attributes for the shelfpack and case.The shelfpack revision 6 label did not contain automatic identification and data capture (aidc) for the unique device identifier (udi) production identifiers.The primary device identifier (di) number usually indicates the lowest level of packaging that is marked with a complete unique device identifier (udi) compliant label.Unique device identifier (udi) compliant label includes both the device identifier and production identifier.Material 305207 shelfpack label has been updated to revision 7 for eumdr to include the unique device identifier and production identifier (udi-pi) barcode.Gudid record update will be submitted to update the primary device identifier (di) number to the shelfpack (gtin: (b)(4); device count: (b)(4).Based on the investigation reported issue is confirmed.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.
Event or Problem Description
Material #:305207 batch#:unknown it was reported that the bd syringe oral 1ml amber label content was incorrect.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Gtin / udi packaging information incorrect in gudid for (b)(4) (bd 305207).

• Brand Name: BD SYRINGE ORAL 1ML AMBER
• 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: 20081095
• Report Number: 1213809-2024-00586
• Device Sequence Number: 12662183
• Product Code: KYW
• UDI-Device Identifier: 50382903052078
• UDI-Public: (01)50382903052078
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown