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

Catalog Number	305209
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
One photo of a 10ml amber oral syringe was received and evaluated.The image shows one loose syringe with the light print on the letters "al" of "oral" and the "s" of "use" on the scale markings.The reported defect cannot be determined from the photo provided.The reported defect was not identified in the photos received, so a root cause could not be established.A device history record review could not be completed as the lot number was unknown.
Event or Problem Description
Material #: 305209.Batch#: unknown.It was reported by customer that wife is a pediatric nurse at (b)(6) 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.Hcps cannot use bd syringes for a variety of activities.Item#(b)(4).Verbatim: rcc received a complaint via email.Email(s) attached.Wife is a pediatric nurse at (b)(6) 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#(b)(4).

• Brand Name: BD ORAL SYRINGE
• Common Device Name: 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
• Report Number: 1213809-2024-00019
• Device Sequence Number: 20729680
• Product Code: KYW
• UDI-Device Identifier: 50382903052092
• UDI-Public: (01)50382903052092
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 07/18/2024

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: Other
• Device Catalogue Number: 305209
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown