MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE; PISTON SYRINGE

Model Number	305500
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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 while using bd allergy syringe with permanently attached needle the sterility was compromised before use.There was no report of patient impact.The following information was provided by the initial reporter: customer stated that there was a single syringe in his pack of 10 that did not have a cap on it.
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: 29-mar-2022.H.6.Investigation: customer returned (1) 1ml, 12.7mm, 28g bd allergy syringe in an open poly bag from lot # 1123578 and a photo of a 1cc syringe without and packaging.Customer returned a photo of a 1cc syringe without any packaging.Customer states that the needle was bent and the tip cap was missing.The photo was examined and exhibited a missing shield and a bent cannula.Due to the batch being unknown, no dhr review can be completed.Root cause cannot be determined at this time as the sample is shown out of the packaging and potentially opened/used.
Event or Problem Description
It was reported while using bd allergy syringe with permanently attached needle the sterility was compromised before use.There was no report of patient impact.The following information was provided by the initial reporter: customer stated that there was a single syringe in his pack of 10 that did not have a cap on it.

• Brand Name: BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE
• 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: 13709998
• Report Number: 1920898-2022-00150
• Device Sequence Number: 5448475
• Product Code: FMF
• UDI-Device Identifier: 30382903055006
• UDI-Public: 30382903055006
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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 Model Number: 305500
• Device Catalogue Number: 305500
• Device Lot Number: UNKNOWN
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/28/2022
• 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: Male