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

Catalog Number 515003

Device Problem Gas/Air Leak (2946)

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

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd phaseal¿ injector luer lock n35 leaks cytotoxic vapors.

Event Description

It was reported that a bd phaseal¿ injector luer lock n35 leaks cytotoxic vapors.

Manufacturer Narrative

Investigation: three injector samples, three connector samples, and three protector samples were received for evaluation by our quality engineer team.A device history record review was performed for the injector lot number, 1805105, and the review did not reveal any quality issues during the production process that could have contributed to this incident.Through visual inspection of the samples, no defects were observed.Leakage testing was performed for each sample and no signs of leakage were observed.The injectors and connectors were attached to an infusion bag and no signs of leakage were observed.The protectors were connected to vials they performed per specification with no signs of leakage.As no signs of leakage, including vapor leakage, were observed, a cause for the reported incident could not be determined.

• 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: 8180393
• MDR Text Key: 131144033
• Report Number: 3003152976-2018-00548
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 515003
• Device Lot Number: 1805105
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other