MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD ORAL SYRINGE

Catalog Number 305220

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that the bd oral syringe label content was incorrect.The following information was provided by the initial reporter: it was reported by customer that they received product with wrong label having different material number.Verbatim: rcc received a complaint via phone.Pir attached.Product complaint - customer called to report that they received mislabel product, the outer cases is listed as (b)(6) lot 3195317, while (b)(4) bags of a 100ea is label (b)(6), the physical product appears to be the outer carton label.Doe (b)(6) 2024, sample available, not used.No pt harm, customer requests replacement (b)(4) of product.

• Brand Name: BD ORAL SYRINGE
• Type of Device: SYRINGE
• 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: 19091076
• MDR Text Key: 340590072
• Report Number: 1213809-2024-00220
• Device Sequence Number: 1
• Product Code: KYW
• UDI-Device Identifier: 50382903052207
• UDI-Public: (01)50382903052207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305220
• Device Lot Number: 3195317
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1