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

Model Number	305945
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/16/2021
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.Device manufacture date: unknown.Investigation summary: since no samples (including photos) were returned for the reported issue of ¿needle stick injury¿, with reported lot # unknown regarding item # 305945, the complaint could not be confirmed, and the root cause is undetermined.If samples are received in the future the complaint will be reopened for further investigation.Unable to complete dhr check as the lot number is unknown.Bd was not able to duplicate or confirm the indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that the bd¿ syringe with permanently attached bd safetyglide¿ safety needle caused a dirty needle stick to the nurse when their thumb slipped past the safety.This complaint was created to capture the 4th of 5 related incidents.The following information was provided by the initial reporter: "increased number of nurse needle sticks that seem to have been with the safety glide syringes.".

• Brand Name: BD SYRINGE WITH PERMANENTLY ATTACHED BD SAFETYGLIDE SAFETY NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11466986
• Report Number: 1920898-2021-00285
• Device Sequence Number: 17154132
• Product Code: MEG
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 305945
• Device Catalogue Number: 305945
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/11/2021
• 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