MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE ORAL 10ML AMBER MDS; CONTAINER, LIQUID MEDICATION, GRADUATED

Catalog Number	305209
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr 9341129: initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Patient problem code: f27 ¿ no patient involvement.Device problem code: a2101 - device markings / labelling problem.
Event or Problem Description
Rcc received a complaint via email.Email(s) attached.The expiry date is not mentioned on the bag with syringes or on the small bag with caps lot#: 0148085.
Additional Manufacturer Narrative
(b)(4) - follow up mdr for correction.Following submission of the initial mdr, it was determined that this complaint is a duplicate of (b)(4) and was not needed.No further action will be taken.
Event or Problem Description
This complaint is a duplicate of (b)(4).

• Brand Name: SYRINGE ORAL 10ML AMBER MDS
• Common Device Name: CONTAINER, LIQUID MEDICATION, GRADUATED
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18312447
• Report Number: 1213809-2023-01445
• Device Sequence Number: 17838572
• Product Code: KYW
• UDI-Device Identifier: 50382903052092
• UDI-Public: (01)50382903052092
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/14/2023

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: 305209
• Device Lot Number: 0148085
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown