MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ SYRINGE AND NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305906
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Pma/510(k)#: k980987(syringe); k951254 (needle).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 that bd safetyglide syringe and needle exhibited the following: "the distal tip of the needle is covered, but there is a portion of the needle that is still exposed, the needles have a lot of play (movement at the connection), and bending." it was also reported that the needle can be removed from the syringe.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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.
Event or Problem Description
It was reported that bd safetyglide syringe and needle exhibited the following: "the distal tip of the needle is covered, but there is a portion of the needle that is still exposed, the needles have a lot of play (movement at the connection), and bending." it was also reported that the needle can be removed from the syringe.No serious injury or medical intervention was reported.

• Brand Name: BD SAFETYGLIDE¿ SYRINGE AND NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7748199
• Report Number: 1213809-2018-00491
• Device Sequence Number: 16563659
• Product Code: FMI
• UDI-Device Identifier: 00382903059065
• UDI-Public: 00382903059065
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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: Other
• Device Catalogue Number: 305906
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 09/24/2018
• 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