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

Catalog Number 305916

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.The initial reporter also notified the fda on sep., 2019.Medwatch report: (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

Material no.: 305916 batch no.: 8324525.It was reported that during use of the bd safetyglide¿ needle medication leaked from the needle during injection.The following information was provided by the initial reporter: the medication leaked from the needle during the injection and patient did not get a full dose.

Event Description

Material no.: 305916, batch no.: 8324525.It was reported that during use of the bd safetyglide¿ needle medication leaked from the needle during injection.The following information was provided by the initial reporter: the medication leaked from the needle during the injection and patient did not get a full dose.

Manufacturer Narrative

Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9209239
• MDR Text Key: 195240634
• Report Number: 1213809-2019-01055
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903059165
• UDI-Public: 30382903059165
• Combination Product (y/n): N
• PMA/PMN Number: K951254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 305916
• Device Lot Number: 8324525
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR