MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB

Catalog Number	305780
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: 305780.Batch#: 0206544.It was reported by customer that allergy nurse proceed to inject medication, opening the box she realized that there was no markings on the syringe to draw the medication.Some of the syringe had their marking looking like they were rubbed off.Mat# 305780 lot 0206544, customer advised event was reported to mckesson rep in october, and a follow up was made october 24th.Mckesson rep advised customer to reach out to bd directly.Verbatim: rcc received a complaint via phone.Pir attached.Allergy nurse proceed to inject medication, opening the box she realized that there was no markings on the syringe to draw the medication.Some of the syringe had their marking looking like they were rubbed off.Mat# 305780 lot 0206544, customer advised event was reported to mckesson rep in october, and a follow up was made october 24th.Mckesson rep advised customer to reach out to bd directly.
Additional Manufacturer Narrative
No sample/photo received for investigation.Based on device history record review, no abnormality was observed during the production of the affected batches.The 1ml syringe part is purchased from bd canaan.The packaging line was reviewed and there is no area that would contribute to the ¿scale marking issue¿.Bd canaan had been notified of this complaint for investigation.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd syringe 1ml ll w/ndl eclipse 25x5/8 rb scale markings missing the following information was provided by the initial reporter; it was reported by customer that allergy nurse proceed to inject medication, opening the box she realized that there was no markings on the syringe to draw the medication.Some of the syringe had their marking looking like they were rubbed off.Mat# 305780 lot 0206544, customer advised event was reported to mckesson rep in october, and a follow up was made october 24th.Mckesson rep advised customer to reach out to bd directly.Verbatim: rcc received a complaint via phone.Pir attached.Allergy nurse proceed to inject medication, opening the box she realized that there was no markings on the syringe to draw the medication.Some of the syringe had their marking looking like they were rubbed off.Mat# 305780 lot 0206544, customer advised event was reported to mckesson rep in october, and a follow up was made october 24th.Mckesson rep advised customer to reach out to bd directly.

• Brand Name: BD SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18297805
• Report Number: 2243072-2023-02161
• Device Sequence Number: 15313107
• Product Code: FMI
• UDI-Device Identifier: 30382903057802
• UDI-Public: (01)30382903057802
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/08/2024

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 Expiration Date: 07/31/2025
• Device Catalogue Number: 305780
• Device Lot Number: 0206544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown