MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ ECCENTRIC LUER SLIP TIP SYRINGE; PISTON SYRINGE

Model Number	300866
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 3 bd¿ eccentric luer slip tip syringe had the incorrect label.The following information was provided by the initial reporter, translated from tectum to english: sku300866 should be for syringe 60ml et, but the label in physical stock showing 50ml luer syringe, please refer to below photos shared by customer.
Additional Manufacturer Narrative
H6: investigation summary: multiple photos were provided to our quality team for investigation.Upon visual inspection of the photos, no manufacturing related defects were observed, the device and all of the labeling is correct.A device history record review did not reveal any quality issues during the production of lot number 2204008.Catalog number 300866 belongs to 50/60ml bdtm eccentric slip tip syringe ce mark sterile, single use syringes.The marking scale of the syringe goes up to 60ml, but the nominal value of the syringe is 50ml.As the labeling of this product is according to bd specifications, there are no defects observed.H3 other text : see h10.
Event or Problem Description
It was reported that 3 bd¿ eccentric luer slip tip syringe had the incorrect label.The following information was provided by the initial reporter, translated from tetum to english: (b)(4) should be for syringe 60ml et, but the label in physical stock showing 50ml luer syringe, please refer to below photos shared by customer.

• Brand Name: BD¿ ECCENTRIC LUER SLIP TIP SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16288536
• Report Number: 3003152976-2023-00012
• Device Sequence Number: 6766638
• Product Code: FMF
• UDI-Device Identifier: 30382903008668
• UDI-Public: (01)30382903008668
• Combination Product (Y/N): N
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: Other
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: 2204008
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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