MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35J; PHASEAL ADMINISTRATION SET

Catalog Number 515008

Device Problems Break (1069); Deformation Due to Compressive Stress (2889)

Patient Problem No Information (3190)

Event Date 03/01/2019

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 the injector was too tight to come off of bd phaseal¿ injector luer lock n35j and the hcp broke it and the needle was exposed after giving navelbine(chemo), the injector was deformed from the beginning, hcp broke the injector when connecting or the drug attached to the injector and it thickened and became a cause of broken etc.

Manufacturer Narrative

Investigation: visual inspection of the returned sample reveals the tip of the safety sleeve was damaged.The injector was functional and successfully attached to the connector.As a lot number was unavailable for this incident, a device history record review could not be completed.Injector needles become exposed if they are not properly disengaged, which also results in safety sleeve breakage.It is important to hold onto the white components of the injector when engaging/disengaging; do not grip the blue safety sleeve.Manufacturing personnel conduct a series of testing and inspections throughout the manufacturing process to avoid defects with our products.The instructions for use must be carefully followed when using the phaseal devices in order to avoid any damage to the product that may result in the device not functioning as intended.

Event Description

It was reported that the injector was too tight to come off of bd phaseal¿ injector luer lock n35j and the hcp broke it and the needle was exposed after giving navelbine(chemo), the injector was deformed from the beginning, hcp broke the injector when connecting or the drug attached to the injector and it thickened and became a cause of broken etc.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35J
• Type of Device: PHASEAL ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8429257
• MDR Text Key: 139196868
• Report Number: 3003152976-2019-00206
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00382905150081
• UDI-Public: 382905150081
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515008
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other