MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB

Model Number	305945
Medical Device Problem Codes	Leak/Splash (1354); Retraction Problem (1536)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	07/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the syringe sftygld 1ml w/ndl 27x1/2 rb experienced a broken safety mechanism, blood exposure -splash, and a post use dirty needle stick injury.Product defects were noted after use.It has not been specified whether any medical intervention was received as a result of the needle stick injury.The following information was provided by the initial reporter: material no: 305945 batch no: 6131957.Safety glide needle cover deployed after tb skin test performed.Able to unlock safetyglide cover which slid back and resulted in a needlestick injury.
Event or Problem Description
It was reported that the syringe sftygld 1ml w/ndl 27x1/2 rb experienced a broken safety mechanism, blood exposure-splash, and a post use dirty needle stick injury.Product defects were noted after use.It has not been specified whether any medical intervention was received as a result of the needle stick injury.The following information was provided by the initial reporter: material no: 305945.Batch no: 6131957.Safety glide needle cover deployed after tb skin test performed.Able to unlock safetyglide cover which slid back and resulted in a needlestick injury.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 6131957.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

• Brand Name: SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10312869
• Report Number: 1920898-2020-00921
• Device Sequence Number: 17000917
• Product Code: FMF
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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 Expiration Date: 05/31/2021
• Device Model Number: 305945
• Device Catalogue Number: 305945
• Device Lot Number: 6131957
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 07/28/2020
• 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