MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE VET SYRINGE 0.3ML X 29G X 12.7MM; PISTON SYRINGE

Model Number	323000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is pending but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 3 vet syringe 0.3ml x 29g x 12.7mm hubs separated.The following information was provided by the initial reporter : the consumer reported that when needle shields were removed the needle hubs separated.  date of event: unknown.Samples: yes.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-07-13.H6: investigation summary customer returned (3) loose 0.3ml u-40 bd insulin syringes.The customer reported when needle shield was removed, needle hub separated.All 3 returned syringes were examined, and all 3 exhibited a detached needle hub/shield assembly.No damage to the barrel tips was observed.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.Bd was able to duplicate or confirm the customer¿s indicated failure.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 3 vet syringe 0.3ml x 29g x 12.7mm hubs separated.The following information was provided by the initial reporter : the consumer reported that when needle shields were removed the needle hubs separated.  date of event: unknown; samples: yes.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.
Event or Problem Description
It was reported that 3 vet syringe 0.3ml x 29g x 12.7mm hubs separated.The following information was provided by the initial reporter : the consumer reported that when needle shields were removed the needle hubs separated.Date of event: unknown.Samples: yes.

• Brand Name: VET SYRINGE 0.3ML X 29G X 12.7MM
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12125820
• Report Number: 1920898-2021-00726
• Device Sequence Number: 19918898
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2021

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: 06/10/2021
• Supplement Date Received by Manufacturer: 07/13/2021; 08/10/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/03/2021; 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1