MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML LL TIP 1ML; SYRINGE, PISTON

Catalog Number	309653
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: 309653, batch#: unknown.It was reported by customer that pharmacy noticed that a certain lot of the bd# 309653 did not have scale markings on them.As their supply chain team began inspecting this product number and lot across the division, they then noticed that bd# 309620 of a certain lot also did not have scale markings verbatim: complaint received via email(s) attached.Pharmacy noticed that a certain lot of the bd# 309653 did not have scale markings on them.As their supply chain team began inspecting this product number and lot across the division, they then noticed that bd# 309620 of a certain lot also did not have scale markings.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
No additional information received.Material #: 309653; batch#: unknown.It was reported by customer that pharmacy noticed that a certain lot of the bd# 309653 did not have scale markings on them.As their supply chain team began inspecting this product number and lot across the division, they then noticed that bd# 309620 of a certain lot also did not have scale markings verbatim: complaint received via email(s) attached.Pharmacy noticed that a certain lot of the bd# 309653 did not have scale markings on them.As their supply chain team began inspecting this product number and lot across the division, they then noticed that bd# 309620 of a certain lot also did not have scale markings.
Additional Manufacturer Narrative
Pr (b)(4) follow up: it was reported certain syringes did not have scale markings on them.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows eight syringes in their packaging blisters.Two have a visible syringe barrel scale graduation.For the remaining six samples, the syringe barrel scale graduation is not visible.No other defects or imperfections were observed.As the lot provided is 'unknown,' a device history record review could not be completed.Verification of the syringe barrel printing process was performed.The settings were correct, and the flow of product was good.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.

• Brand Name: SYRINGE 50ML LL TIP 1ML
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19923450
• Report Number: 1911916-2024-00580
• Device Sequence Number: 7218800
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: (01)30382903096207
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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,Followup
• Report Date (Section B): 08/08/2024

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: Health Professional
• Device Catalogue Number: 309653
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown