MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; SYRINGE, PISTON

Model Number	328431
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle that when plunger cap is removed, the plunger rod falls out of the syringe and stays in the plunger cap.The following information was provided by the initial reporter: consumer / pet owner reported plunger cap hard to remove - when removed the plunger rod falls out of syringe and stays in the plunger cap.
Additional Manufacturer Narrative
Date of event.:the date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: customer returned a total of 16 syringes across 3 opened polybags for 0.3ml, 30 gauge, 12.7mm syringes from lot 1277006.These samples received shield pull force testing.The specification states that all pull forces within the range of 0.85 lbs to 5.95 lbs are acceptable.None of the samples tested outside of the required range and none of the samples disassembled during testing.A review of the device history record was completed for batch # 2031540 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, embecta was unable to confirm the customer¿s indicated failure of the plunger rod separating.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
Event or Problem Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle that when plunger cap is removed, the plunger rod falls out of the syringe and stays in the plunger cap.The following information was provided by the initial reporter: consumer / pet owner reported plunger cap hard to remove - when removed the plunger rod falls out of syringe and stays in the plunger cap.

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• Common Device Name: SYRINGE, PISTON
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14937806
• Report Number: 1920898-2022-00431
• Device Sequence Number: 20370376
• Product Code: FMF
• UDI-Device Identifier: 00382908431033
• UDI-Public: 00382908431033
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212499
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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: 328431
• Device Catalogue Number: 328431
• Device Lot Number: 2031540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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