MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOK¿ SYRINGE; PISTON SYRINGE

Model Number	300613
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd plastipak¿ luer-lok¿ syringe was missing scale markings.The following information was provided by the initial reporter: there is no print; no scales on the syringe.
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 the bd plastipak¿ luer-lok¿ syringe was missing scale markings.The following information was provided by the initial reporter: there is no print; no scales on the syringe.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 13-jun-2022.Investigation summary: one sample was provided to our quality team for investigation.Through visual inspection, it was observed that the scale was not printed on the syringe, verifying the reported incident.A device history review was performed for reported lot 2112077, finding one annotation related to this incident.In the marking machine, a failure was detected with the inertia brake.Once detected, the mechanical team immediately repaired the failure.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 our investigation, this incident was determined to be caused by the issue detected during manufacturing.H3 other text : see h10.

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ 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: 14496310
• Report Number: 3003152976-2022-00232
• Device Sequence Number: 6009317
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: 30382903006138
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 07/27/2022

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 Model Number: 300613
• Device Catalogue Number: 300613
• Device Lot Number: 2112077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• 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