MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK¿ SYRINGE; PISTON SYRINGE

Catalog Number	302553
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 the bd plastipak¿ syringe had missing scale markings.This complaint was created to capture the 4th of 7 related incidents.The following information was provided by the initial reporter, translated from spanish: "syringes without scale or with partially erased scale.".
Event or Problem Description
Additional information received: syringes without scale or with partially erased scale.____ customer provided to us the additional information on 15.Sep.2023.- the reported batch (2117458) is unknown, it does not correspond to a syringe, could you kindly tell us what the batch of the product is? is that lot a needle, was the needle used? what was the detour? 2045792.- was the reported incident noticed before, during or after use? before.- has there been any harm to the patient/healthcare professional? (detail) no.- was there a need for medical and/or surgical intervention due to what occurred (imaging examinations, surgery, medication administration, etc.)? (detail) no.- has there been exposure of blood or chemotherapy to the mucous membranes or skin? (detail) no.- do you have products available for evaluation? already collected by you.- could you send photos of the sample? yes / already sent in the incident emails.- could you send the quantity for this product? 39.
Additional Manufacturer Narrative
Fifty six syringe samples received.Upon visual evaluation, scale marking is missing from the syringes.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the quality team's investigation, possible root cause is associated with operator failure to segregate the syringes.Actions will be implemented including installation and detection of system, and manufacturing personnel have been notified and additional training to reinforce proper assembly has been performed.

• Brand Name: BD PLASTIPAK¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17770438
• Report Number: 9614033-2023-00109
• Device Sequence Number: 20621361
• Product Code: FMF
• UDI-Device Identifier: 07501073025530
• UDI-Public: (01)07501073025530
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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 Catalogue Number: 302553
• Device Lot Number: 2045792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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