MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD ¿ LUER-LOK SYRINGE PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Catalog Number	309589
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.No lot # provided.The customer's name and address is unknown.The state of (b)(6) has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use, a bd¿ luer-lok syringe precisionglide needle was found leaking as consumer reported they were ¿giving a shot of b12, and the medication leaked outside of the syringe and onto the floor.¿ there was no report of injury or medical intervention reported.
Additional Manufacturer Narrative
Investigation summary: lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Since no samples displaying the condition reported are available for examination, bd was unable to fully investigate this incident.No root cause can be determined as no samples were received.Examination of the product involved may provide clarification as to the cause for the reported failure.Based on no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failures.Investigation conclusion: no root cause can be determined as no samples were received.

• Brand Name: BD ¿ LUER-LOK SYRINGE PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7224694
• Report Number: 1213809-2018-00015
• Device Sequence Number: 16436489
• Product Code: FMF
• UDI-Device Identifier: 30382903095897
• UDI-Public: 30382903095897
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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: Lay User/Patient
• Device Catalogue Number: 309589
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 03/07/2018
• 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