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

Catalog Number	302553
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 bd plastipak¿ syringe scale marking lines were not located at the right angles on the barrel.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from spanish: "graduation lines must be located at right angles to the longitudinal axis of the cylinder or barrel.".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: two photos received by our quality team for investigation.Upon visual inspection, product label information catalog: 302553, batch number: 7230949 is displayed, the product is expired.No other defects or issues can be observed, therefore this incident is not confirmed.The samples have already passed their expiration date, therefore bd does not guarantee that the product presents any alteration or meeting specification.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported that 2 bd plastipak¿ syringe scale marking lines were not located at the right angles on the barrel.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from spanish: "graduation lines must be located at right angles to the longitudinal axis of the cylinder or barrel.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15499219
• Report Number: 9614033-2022-00078
• Device Sequence Number: 5970091
• Product Code: FMF
• UDI-Device Identifier: 07501073025530
• UDI-Public: (01)07501073025530
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K151766
• 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): 10/03/2022

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: 07/31/2022
• Device Catalogue Number: 302553
• Device Lot Number: 7230949
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2017
• 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