MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP SYRINGE WITH ATTACHED NEEDLE; HYPODERMIC SYRINGE W/ NEEDLE

Catalog Number	309625
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.The customer's name and address is unknown.(b)(6) has been used as a default.A sample is not available for evaluation.However, a no sample investigation will be completed.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd¿ slip tip syringe with attached needle (intradermal bevel, sterile, single use) leaked during use.There was no report of exposure, injury or medical interventions.
Additional Manufacturer Narrative
Investigation summary: no samples or photos displaying the condition reported are available for examination.We were unable to fully investigate this incident.A review of the device history record could not be performed as a lot number was not provided for this incident.Investigation conclusion: no root cause can be determined as no samples were received.

• Brand Name: BD¿ SLIP TIP SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: HYPODERMIC SYRINGE W/ NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7434368
• Report Number: 1213809-2018-00247
• Device Sequence Number: 11049349
• Product Code: FMF
• UDI-Device Identifier: 30382903096252
• UDI-Public: 30382903096252
• 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): 04/20/2018

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: 309625
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2016
• Supplement Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 04/24/2018
• 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