MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE SFTYGLD 1ML W/NDL 26X3/8 IB; PISTON SYRINGE

Catalog Number	305946
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ syringe sftygld 1ml w/ndl 26x3/8 ib leaked during injection.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: customer returned 1ml, 10mm, 26g bd safetyglide tb syringes (cat # 305946, lot # 3354070) in sealed blister packs.Customer states that the liquid sprays everywhere and there is thus a leakage when injecting.All returned syringes were tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 3354070.All inspections and challenges were performed per the applicable operations qc specifications.There were zero notifications noted that pertained to the complaint.Based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that bd¿ syringe sftygld 1ml w/ndl 26x3/8 ib leaked during injection.No serious injury or medical intervention was reported.

• Brand Name: BD SYRINGE SFTYGLD 1ML W/NDL 26X3/8 IB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8280524
• Report Number: 1920898-2019-00111
• Device Sequence Number: 19310835
• Product Code: FMF
• UDI-Device Identifier: 30382903059462
• UDI-Public: 30382903059462
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 03/13/2019

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: 01/31/2019
• Device Catalogue Number: 305946
• Device Lot Number: 3354070
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/13/2019
• 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