MAUDE Adverse Event Report: BECTON DICKINSON BD LUER-LOK¿ TIP SYRINGE

Catalog Number 309604

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.There are two bd locations where this bd device may have been manufactured.A 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.Investigation summary: one photo depicting a blisterpack label from a 10ml syringe, lot number unknown (p/n 309604) received at bd.Unable to perform an evaluation based on the photo received, therefore we were unable to fully investigate this incident, thus a root cause could not be determined.Furthermore, the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.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.Investigation conclusion: one photo depicting a blisterpack label from a 10ml syringe, lot number unknown (p/n 309604) received at bd.Unable to perform an evaluation based on the photo received.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.Lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Unconfirmed: bd was not able to confirm the customer¿s indicated failure root cause description: no root cause can be determined based on the photo received.Rationale: capa is not required at this time.

Event Description

It was reported that the bd luer-lok¿ tip syringe "did not have a good seal and would not work".Found before use.No reports of serious injury or medical intervention noted.

• Brand Name: BD LUER-LOK¿ TIP 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7636576
• MDR Text Key: 112446280
• Report Number: 2243072-2018-00418
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096046
• UDI-Public: 00382903096046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• 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
• Patient Outcome(s): Other