MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD® PLASTIC NRFIT¿ SYRINGE; PISTON SYRINGE

Catalog Number	400051
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that thebd® plastic nrfit¿ syringe had scale marking issues.The following was translated from german to english: while performing the study procedure the physician noted that the scale marking on the nrfit syringe comes off after having been touched a few times.The device still fulfilled its purpose, the use was not affected in any way, since at the time the scale was not readable any more the syringe had already fulfilled its function.The customer merely wanted to mention that the marking is not very durable.
Additional Manufacturer Narrative
H3.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® plastic nrfit¿ syringe had scale marking issues.The following was translated from german to english: while performing the study procedures the physician noted that the scale marking on the nrfit syringe comes off after having been touched a few times.The device still fullfilled its purpose, the use was not affected in any way, since at the time the scale was not readable any more the syringe had already fulfilled its function.The customer merely wanted to mention that the marking is not very durable.
Additional Manufacturer Narrative
H6: investigation summary one photo was provided to our quality team for investigation.The image shows a loose syringe with partial missing print of the minor and major graduation lines of the scale markings area.Based upon the verbatim the condition occurred after being ¿touched a few times¿.The reported condition is due to handling and wear of the syringe, not a true defect.Therefore, no corrective actions are necessary at this time.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.

• Brand Name: BD® PLASTIC NRFIT¿ SYRINGE
• Common Device Name: PISTON 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17777142
• Report Number: 1213809-2023-01043
• Device Sequence Number: 18080140
• Product Code: FMF
• UDI-Device Identifier: 00382904000516
• UDI-Public: (01)00382904000516
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K192538
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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 Expiration Date: 02/28/2025
• Device Catalogue Number: 400051
• Device Lot Number: 0083149
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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