MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PRECISION GLIDE¿ ALLERGY SYRINGE/NEEDLE; SYRINGE WITH NEEDLE

Model Number	305536
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
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 anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd precision glide¿ allergy syringe/needle the tip/luer of the syringe broke off.The following information was provided by the initial reporter.The customer stated: the medical professional reported, "the heads of the syringe are falling/breaking off.".
Additional Manufacturer Narrative
H6: investigation summary: customer returned a photo of a 1/2ml syringe.Customer states that the heads of the syringe are falling/breaking off.The photo was examined and exhibited the hub-needle/shield assembly separated from the barrel.A review of the device history record was completed for batch # 0104220.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure (hub separates).Capa (b)(4) has been opened to address this issue.H3 other text: see h10.
Event or Problem Description
It was reported when using the bd precision glide¿ allergy syringe/needle the tip/luer of the syringe broke off.The following information was provided by the initial reporter.The customer stated: the medical professional reported, "the heads of the syringe are falling/breaking off.".

• Brand Name: BD PRECISION GLIDE¿ ALLERGY SYRINGE/NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• 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: 12709960
• Report Number: 1920898-2021-01115
• Device Sequence Number: 17280855
• Product Code: FMF
• UDI-Device Identifier: 30382903055365
• UDI-Public: 30382903055365
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 305536
• Device Catalogue Number: 305536
• Device Lot Number: 0104220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2020
• 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