MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PET SYRINGES, 0.3ML X 12MM U-40; PISTON SYRINGE

Model Number	323000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd pet syringes, 0.3ml x 12mm u-40 the plunger rod was difficult to move and the hub separated from device.The following information was provided by the initial reporter: pet owner reported that the needle hub separated and was stuck inside of the shield.Also reported that the plunger rod is difficult to move.
Additional Manufacturer Narrative
H6: investigation summary customer returned three 0.3ml syringes.The syringes have had their needle shields and hubs separate from the barrels.The hubs have become lodged inside the shields.There is no damage to either the connectors at the distal tip of the barrels or their respective needle hubs.Additionally, it was observed that, when fully depressed, it was difficult to draw back the plunger.With sufficient force, the plunger would release from the top of the barrel of the syringe and could then be drawn back without extra effort.Upon inspection, it was noted that the stopper was raised, not sitting in its intended location at the distal tip of the plunger rod, but slightly disconnected from it.A review of the device history record was completed for batch # 0174596 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Based on the samples received, bd was able to confirm the customer¿s indicated failure of the plunger rod being difficult to move.Based on the samples received, bd was able to confirm the customer¿s indicated failure of needle hub separation.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Capa pr1630423 has been opened to address this issue.H3 other text : see h10.
Event or Problem Description
It was reported that bd pet syringes, 0.3ml x 12mm u-40 the plunger rod was difficult to move and the hub separated from device.The following information was provided by the initial reporter: pet owner reported that the needle hub separated and was stuck inside of the shield.Also reported that the plunger rod is difficult to move.

• Brand Name: BD PET SYRINGES, 0.3ML X 12MM U-40
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12193571
• Report Number: 1920898-2021-00778
• Device Sequence Number: 3509416
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: Lay User/Patient
• Device Expiration Date: 06/30/2025
• Device Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: 0174596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1