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

Catalog Number 305209

Device Problem Volume Accuracy Problem (1675)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

B.3.The date received by manufacturer has been used for this field.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 had a scale marking issue.The following information was provided by the initial reporter: "wife is a pediatric nurse at (b)(6) hospital and in passing mentioned substituting baxter oral syringes for bd oral syringes.In doing so she advised the staff feel the quality of the bd syringes is not adequate for use in various functions.The staff has been instructed not to use the bd syringes for various activities like pushing oral medication or feeding via tubes as they slip off the tubes.The graduations on the outside of the syringe also wipe off easily while the baxter cannot even be scratched off.This means the hcp's do not have an accurate measurement of the liquid in the syringe.Hcp's cannot use bd syringes for a variety of activities." item#305209.

• 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: 18558564
• MDR Text Key: 333456701
• Report Number: 1213809-2024-00019
• Device Sequence Number: 1
• Product Code: KYW
• UDI-Device Identifier: 50382903052092
• UDI-Public: (01)50382903052092
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305209
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1