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

Catalog Number 515003

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Chemical Exposure (2570)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that after use of the bd phaseal¿ injector luer lock n35 as the "clinician disconnected the chemo line, as it had appeared to completely infuse.Disconnected the injector and found bead of doxi on the tip of the injector and chemo in her hands.Patient's pillow had spot of red on it.".

Event Description

It was reported that after use of the bd phaseal¿ injector luer lock n35 as the "clinician disconnected the chemo line, as it had appeared to completely infuse.Disconnected the injector and found bead of doxi on the tip of the injector and chemo in her hands.The nurse was wearing protective gear at the time gown, double gloves.Patient's pillow had spot of red on it.

Manufacturer Narrative

Type of reportable events corrected to malfunction.

Event Description

It was reported that after use of the bd phaseal¿ injector luer lock n35 as the "clinician disconnected the chemo line, as it had appeared to completely infuse.Disconnected the injector and found bead of doxi on the tip of the injector and chemo in her hands.Patient's pillow had spot of red on it.".

Manufacturer Narrative

Investigation summary: two picture samples were received for evaluation by our quality engineer.A device history record review was completed for the possible lot number provided (1804103) and no quality issues were found during the production process that could have contributed to this incident.Fifteen retained samples of the same lot number were obtained for further investigation.Investigation conclusion: through visual inspection of the picture samples, the leak is not clearly shown, but it seems that it resulted from the holes of the safety sleeve.Visual inspection of the retained samples did not reveal any defects.Functionality testing revealed all retained samples were within specifications and there were no signs of leakage observed.Root cause description: based on the investigation results, a definite cause for the reported incident could not be determined.Rationale: complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.

• 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: 8176524
• MDR Text Key: 130769495
• Report Number: 3003152976-2018-00571
• 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: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 515003
• Device Lot Number: 1804103
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 11/23/2018; 11/23/2018
• Supplement Dates FDA Received: 12/27/2018; 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other