MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿¿ TIP WITH BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303346
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Two photos were received and evaluated.One photo displayed the graphic side of a 3ml syringe (p/n 303346) from batch #1239102.One photo displayed a vial with unknown medication that appeared to show a piece of sheared rubber present inside of it.Please refer to the directions for use present on the back of the syringe box.Bd syringes with blunt plastic cannula are specifically designed for use with preslit injection sites.They are not compatible with other injection sites.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.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.
Event or Problem Description
It was reported that foreign matter was found in bd luer-lok¿ tip with blunt plastic cannula.There was no report of patient impact.The following information was provided by the initial reporter: "it was reported fm.We have had a med vial rubber stopper shearing when a clinician is using the ref(b)(4) syringe w blunt plastic cannula.This has happened multiple times and the fragment has been aspirated back into the syringe and caught by the nurse prior to injection.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Two photos were received and evaluated.One photo displayed the graphic side of a 3ml syringe (p/n 303346) from batch #1239102.One photo displayed a vial with unknown medication that appeared to show a piece of sheared rubber present inside of it.Please refer to the directions for use present on the back of the syringe box.Bd syringes with blunt plastic cannula are specifically designed for use with preslit injection sites.They are not compatible with other injection sites.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.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.
Event or Problem Description
It was reported that foreign matter was found in bd luer-lok¿ tip with blunt plastic cannula.There was no report of patient impact.The following information was provided by the initial reporter: "it was reported fm.We have had a med vial rubber stopper shearing when a clinician is using the ref 303346 syringe w blunt plastic cannula.This has happened multiple times and the fragment has been aspirated back into the syringe and caught by the nurse prior to injection.".

• Brand Name: BD LUER-LOK¿¿ TIP 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: 13098575
• Report Number: 1213809-2021-00823
• Device Sequence Number: 16646180
• Product Code: FMI
• UDI-Device Identifier: 30382903033462
• UDI-Public: 30382903033462
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2021

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: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 303346
• Device Catalogue Number: 303346
• Device Lot Number: 1239102
• 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: 11/30/2021
• Initial Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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