MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGES 3/10ML; PISTON SYRINGE

Model Number	328431
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 2 bd ultra-fine" insulin syringes 3/10ml experienced hub separation from the device.The following information was provided by the initial reporter: consumer reported, when he removed needle shield, needle hub separated.Stated, 2 affected last night, ((b)(6) 2021) but its happened more than twice from box he is reporting.Lot: 0055954, catalog: 328431, date of event: (b)(6) 2021.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/18/2021.H.6.Investigation: customer returned three syringes with no pouch for identification.All three syringes feature 0.3ml graduation markings.The first syringe featured its needle shield and hub having separated from the barrel.The hub has become lodged inside the shield.There is no damage to either the connector at the distal tip of the barrel or its respective needle hub.No signs of use and no other defects found.The two remaining syringes were returned fully intact.Removing the needle shields found that the hubs were properly attached to the barrel of the syringe.A needle shield pull force test was performed on each of these syringes.The needle shields required 4.55 lbs and 4.31 lbs of force to be removed.The specification states that all pull forces within the range of 0.85 lbs to 5.95 lbs are acceptable.With the needle hubs attached and both of the needle shields being within pull force specification, the report of the hubs separating from the barrels could not be confirmed for these samples.A review of the device history record was completed for batch # 0055954 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Root cause for this defect cannot be determined.Capa#1630423 was initiated.
Event or Problem Description
It was reported that 2 bd ultra-fine¿ insulin syringes 3/10ml experienced hub separation from the device.The following information was provided by the initial reporter: consumer reported, when he removed needle shield, needle hub separated.Stated, 2 affected last night, ((b)(6) 2021) but its happened more than twice from box he is reporting.Lot: 0055954, catalog: 328431, date of event: (b)(6) 2021.

• Brand Name: BD ULTRA-FINE INSULIN SYRINGES 3/10ML
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11558658
• Report Number: 1920898-2021-00339
• Device Sequence Number: 19790663
• Product Code: FMF
• UDI-Device Identifier: 00382908431033
• UDI-Public: 00382908431033
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 03/31/2025
• Device Model Number: 328431
• Device Catalogue Number: 328431
• Device Lot Number: 0055954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1