MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 50ML S/T LATEX FREE CONFIGURE; PISTON SYRINGE

Model Number	309654
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a device history record review was completed for provided material number 309654 and lot number 9133522.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, one sample was received for evaluation by our quality team.The sample came in an opened packaging blister and is a 60ml syringe.The scale marking is missing and no other defects or imperfections were observed.It could be possible for this defect to occur if the printing drum pad lost pressure inducing the symptom reported by the customer.The equipment was inspected and was found to be working satisfactorily.Based on the investigation with the returned sample analysis the symptom reported by the customer is confirmed.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the syringe 50ml s/t latex free configure had no scale markings.The following information was provided by the initial reporter: "bd 60ml syringe does not have measurement markings.".

• Brand Name: SYRINGE 50ML S/T LATEX FREE CONFIGURE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11586099
• Report Number: 1911916-2021-00257
• Device Sequence Number: 4781419
• Product Code: FMF
• UDI-Device Identifier: 30382903096542
• UDI-Public: 30382903096542
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: 04/30/2024
• Device Model Number: 309654
• Device Catalogue Number: 309654
• Device Lot Number: 9133522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1