MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 1/2 IN., 1 ML; PISTON SYRINGE

Model Number	305540
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
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 prior to use with a bd¿ allergy syringe with permanently attached needle 27 g x 1/2 in., 1 ml, foreign matter was found on the needle.The following information was provided by the initial reporter: there was some lint on the needles coming out of a fresh new tray.
Additional Manufacturer Narrative
Investigation summary: customer returned photos of 1cc syringes with a tray from lot # 1201810.Customer states that the product had lint on the needlesthe photos were examined and exhibited an unknown material on the cannula shaft.A review of the device history record was completed for batch #1201810.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 confirm the customer¿s indicated failure (fm).Root cause for the fm issue cannot be determined at this time.H3 other text : see h10.
Event or Problem Description
It was reported that prior to use with a bd¿ allergy syringe with permanently attached needle 27 g x 1/2 in., 1 ml, foreign matter was found on the needle.The following information was provided by the initial reporter: there was some lint on the needles coming out of a fresh new tray.

• Brand Name: BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 1/2 IN., 1 ML
• 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: 13636933
• Report Number: 1920898-2022-00134
• Device Sequence Number: 2213580
• Product Code: FMF
• UDI-Device Identifier: 30382903055402
• UDI-Public: 30382903055402
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2022

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: 08/31/2026
• Device Model Number: 305540
• Device Catalogue Number: 305540
• Device Lot Number: 1201810
• 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: 02/16/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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