MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK (N35C); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515005

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported after removing the bd phaseal¿ injector luer lock (n35c), the needle was exposed.No medical interventions reported.

Manufacturer Narrative

Results: a review of the device history record revealed no irregularities during the manufacture of the reported lot # 7108712.Pictures received do not show the needle exposed.The sample arrived without the needle exposed -the injector was evaluated and it was confirmed that the grips were damage they have been forced and they are not well aligned with the grips of the piston.The safety sleeve is loose and it can be moved: it is broken.This explained the needle exposure.Conclusion: the sample arrived without the needle exposed but with the grips damaged.It was possible to duplicate the defect and it was also possible to keep the sample without the needle exposed again.Bad handling of the injector.It seems that the injector was removed without pulling the injector back: the grips are removed from their place, safety sleeve broken and needle exposure happen.Cause is a bad handling of the device.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK (N35C)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6799137
• MDR Text Key: 83007240
• Report Number: 3003152976-2017-00015
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 515005
• Device Lot Number: 1604008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• 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