MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE; HYPODERMIC NEEDLE

Catalog Number	309596
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported there was difficult plunger movement found while using a 3 ml bd safety-lok¿ syringe with detachable needle as the consumer stated "the syringe did not draw up the medication." there was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: sample evaluation: a single loose 3ml safety-lok syringe and two opened empty safety-lok 3ml syringe packages were received, confirmed to be from batch # 5245904 (p/n 309596).The sample was visually evaluated.The syringe was found to have pink and red fluid residue at the needle tip, inside the hub and the syringe.The plunger was pulled back and forward - the movement was smooth with no resistance or any issues.No defects were observed.The safety mechanism of the syringe was activated and the sample was contaminated, therefore, no other evaluation could be performed.Product defect could not be confirmed based on the sample received.Dhr review for batch 5245904 (p/n 309596): manufacturing dates: 05/03/2014 to 05/04/2014.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 5245904 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Investigation conclusion: product defect could not be confirmed based on the sample received.

• Brand Name: BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7515014
• Report Number: 1213809-2018-00313
• Device Sequence Number: 1704066
• Product Code: FMI
• UDI-Device Identifier: 30382903095965
• UDI-Public: 30382903095965
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• 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): 06/01/2018

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 Expiration Date: 08/31/2020
• Device Catalogue Number: 309596
• Device Lot Number: 5245904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/01/2018
• 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