MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515003

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter phone #: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that needle was exposed causing a needle stick with a bd phaseal¿ injector luer lock n35.The following information was provided by the initial reporter: it was reported that needle was exposed causing a needle stick.User error rn luer connected the n35 due to lack of education and training.

Event Description

It was reported that needle was exposed causing a needle stick with a bd phaseal¿ injector luer lock n35.The following information was provided by the initial reporter: it was reported that needle was exposed causing a needle stick.User error rn luer connected the n35 due to lack of education and training.

Manufacturer Narrative

H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident and a root cause could be determined.A device history review could not be completed as no batch number was provided.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8937313
• MDR Text Key: 155846200
• Report Number: 3003152976-2019-00585
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905150037
• UDI-Public: 30382905150037
• Combination Product (y/n): N
• PMA/PMN Number: K140591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515003
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other