MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PMCF-SAFETYGLIDE-SYRINGE

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Material Protrusion/Extrusion (2979)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed.And the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Initial reporter additional phone#: (b)(6).Device manufacture date: unknown investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: 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.Root cause description: no root cause can be determined as no samples were received.Rationale: since no samples displaying the reported condition were received corrective actions are not necessary.

Event Description

It was reported that unspecified bd" pmcf-safetyglide-syringe needle was clogged on 3 occasions, the needle pulled out of the hub on 3 occasions, and leaked on 3 occasions.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported via survey response that the clinician experienced needle clogged (3), needle pulled out of hub (3), leakage (3).Additional information related to what leaked and from where states: "insulin" "syringe".

• Brand Name: UNSPECIFIED BD PMCF-SAFETYGLIDE-SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11632289
• MDR Text Key: 245794372
• Report Number: 2243072-2021-01005
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1