MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTERLINK¿ 10 ML SYRINGE WITH BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303348
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Bd syringes with blunt plastic cannula are specifically designed for use with preslit injection sites.They are not compatible with other injection sites.This is not the intended use of this product, hypodermic needles designed to puncture vials would provide a proper application.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.It is likely based on description that this product is not being used for its intended application.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 while using bd interlink¿ 10 ml syringe with blunt plastic cannula coring occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by customer that after the medication vial was punctured with the syringe the vial was noted to have retained shards of the rubber stopper from the top of the vial.After the medication vial was punctured with the syringe, the vial was noted to have retained shards of the rubber stopper from the top of the vial.

• Brand Name: BD INTERLINK¿ 10 ML SYRINGE WITH BLUNT PLASTIC CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15004562
• Report Number: 1213809-2022-00391
• Device Sequence Number: 1535220
• Product Code: FMI
• UDI-Device Identifier: 00382903033485
• UDI-Public: 00382903033485
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 303348
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown