MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA; PISTON SYRINGE

Model Number	329420
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.
Event or Problem Description
It was reported that syringe 1.0ml 28ga 1/2in bls 500 sus ca needle separated from the hub and patient went to the er and received x-rays to determine if the needle remained in his arm.The following information was provided by the initial reporter: "it was reported that after the injection the patient and person administering noted that the needle was missing.After going to the er and having an x-ray performed, it was confirmed that no needle was present in the patient's arm.The syringe was x-rayed and it indicated that the needle was in the barrel of the syringe.".
Event or Problem Description
It was reported that syringe 1.0ml 28ga 1/2in bls 500 sus ca needle separated from the hub and patient went to the er and received x-rays to determine if the needle remained in his arm.The following information was provided by the initial reporter: "it was reported that after the injection the patient and person administering noted that the needle was missing.After going to the er and having an x-ray performed, it was confirmed that no needle was present in the patient's arm.The syringe was x-rayed and it indicated that the needle was in the barrel of the syringe.".
Additional Manufacturer Narrative
H.6.Investigation: no samples were returned as of 23 april 2020 therefore the investigation was performed based on the photos provided.Customer provided two (2) photos of a 1ml bd insulin syringe from lot 4160731.It was reported that after the injection the patient and person administering noted that the needle was missing.Both photos were reviewed and no evidence of manufacturing defect could be determined from the photos provided.Since no defects were observed in the provided photos the alleged issues could not be confirmed.A review of the device history record was completed for batch # 4160731.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h.10.

• Brand Name: SYRINGE 1.0ML 28GA 1/2IN BLS 500 SUS CA
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9960122
• Report Number: 1920898-2020-00373
• Device Sequence Number: 2438284
• Product Code: FMF
• UDI-Device Identifier: 30382903294207
• UDI-Public: 30382903294207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 329420
• Device Catalogue Number: 329420
• Device Lot Number: 4160731
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other