MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE ORAL 3ML CLEAR; SYRINGE, PISTON

Catalog Number	305220
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd syringe oral 3ml clear stopper was defective / damaged it was reported by customer that they have had to dispose of several of our syringes already from one bag because the rubber part inside is crooked and makes his dosage inaccurate.Verbatim: rcc received a complaint via phone.Pir attached.Hello, my son is a transplant recipient and relies on accurate medication dosages.I have had to dispose of several of your syringes already from one bag because the rubber part inside is crooked and makes his dosage inaccurate.
Additional Manufacturer Narrative
Two photos of 3ml oral syringe were received and evaluated.One photo shows the bag label of the package with all applicable product information.The next photo shows a loose syringe with the stopper slightly askew, however it cannot be measured.The reported defect cannot be confirmed from the photo provided.The condition observed is acceptable per product specification.A physical sample is required for a more thorough evaluation and potential root cause determination.Therefore, no corrective action is required currently.Lot 1323425 is considered in compliance with our product specification requirements.A device history record review was completed for provided lot number 1323425 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
Material #: unknown batch #: unknown.It was reported by customer that they have had to dispose of several of our syringes already from one bag because the rubber part inside is crooked and makes his dosage inaccurate.Verbatim: rcc received a complaint via phone.Pir attached.Hello, my son is a transplant recipient and relies on accurate medication dosages.I have had to dispose of several of your syringes already from one bag because the rubber part inside is crooked and makes his dosage inaccurate.

• Brand Name: BD SYRINGE ORAL 3ML CLEAR
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 18455008
• Report Number: 1213809-2023-01514
• Device Sequence Number: 19608161
• Product Code: KYW
• UDI-Device Identifier: 50382903052207
• UDI-Public: (01)50382903052207
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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): 07/02/2024

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: Lay User/Patient
• Device Catalogue Number: 305220
• Device Lot Number: 1323425
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown