MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML VET U40 29GA 12.7MM

Model Number	323000
Medical Device Problem Codes	Defective Component (2292); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8351978, medical device expiration date: 2024-01-31, device manufacture date: 2018-12-17, medical device lot #: 0174596, medical device expiration date: 2025-06-30, device manufacture date: 2020-06-22.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 bd syringe 0.3ml vet u40 29ga 12.7mm experienced 2 cases of hub separation from the device, and 2 cases of stopper deformation.The following information was provided by the initial reporter: i have been using this product for more than 3 1/2 years.I have noticed an increase in defective syringes.The defects include but are not limited to: needle breaks off and is stuck in the red cap.Needle is bent in the red cap.Black indicator is distorted /damaged.
Additional Manufacturer Narrative
H.6.Investigation: customer returned a total of 7 0.3ml syringes.The polybag(s) were not provided for further identification.Of the returned samples, 5 had needle shields and hubs separate from their barrels.The hubs have become lodged inside the shields.There is no damage to either the connector at the distal tip of the barrel or its respective needle hub.Additionally, 1 syringe featured a needle bent slightly to one side at its base.The last syringe features a rubber stopper that appears to be dragging inside the barrel.Functional testing found moving the stopper to be difficult regardless of direction.A review of the device history record was completed for batch# 8351978.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.A review of the device history record was completed for batch # 0174596 all inspections were performed per the applicable operations qc specifications.All inspections and challenges 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 needle hub separation.Based on the samples received, bd was able to confirm the customer¿s indicated failure of the stopper dragging in the syringe barrel.Dhr, l2l dispatches, logbook entries were looked at, nothing was found pertaining to this defect.Root cause for this defect cannot be determined.Capa#1630423 was initiated.H3 other text : see h.10.
Event or Problem Description
It was reported that bd syringe 0.3ml vet u40 29ga 12.7mm experienced 2 cases of hub separation from the device, and 2 cases of stopper deformation.The following information was provided by the initial reporter: i have been using this product for more than 3 1/2 years.I have noticed an increase in defective syringes.The defects include but are not limited to: -needle breaks off and is stuck in the red cap -needle is bent in the red cap -black indicator is distorted /damaged.

• Brand Name: BD SYRINGE 0.3ML VET U40 29GA 12.7MM
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12906364
• Report Number: 1920898-2021-01251
• Device Sequence Number: 17095905
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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 Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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