MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION¿ INSULIN SYRINGE; PISTON SYRINGE

Model Number	328506
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using relion¿ insulin syringe a crack in the barrel was discovered and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: material no.328506, batch no.1116704.Consumer reported that there is a crack in the barrel of the syringe near the needle hub.Barrel of syringe leaking.
Event or Problem Description
It was reported while using relion¿ insulin syringe a crack in the barrel was discovered and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: material no.328506 batch no.1116704.Consumer reported that there is a crack in the barrel of the syringe near the needle hub.Barrel of syringe leaking.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 07-feb-2022.H.6.Investigation: customer returned (1) 1ml insulin syringe from lot# 1116704.The customer reported that there is a crack in the barrel of the syringe near the needle hub and the barrel is leaking.The returned sample was examined, and it was observed that the barrel featured several cracks ranging between the 0- and 20- unit scale markings.The damage to the barrel could lead to leakage during use.A review of the device history record was completed for batch# 1116704.All inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Root cause: l2l was created for damaged barrels.H3 other text : see h.10.

• Brand Name: RELION¿ INSULIN SYRINGE
• Common Device Name: PISTON 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13310333
• Report Number: 1920898-2022-00018
• Device Sequence Number: 14289434
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: Other
• Device Expiration Date: 05/31/2026
• Device Model Number: 328506
• Device Catalogue Number: 328506
• Device Lot Number: 1116704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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