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

Catalog Number 515003

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(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 the bd phaseal¿ injector luer lock n35 safety sleeve broke and the "whole system" detached from the needle.

Manufacturer Narrative

Describe event or problem: it was reported that the bd phaseal¿ injector luer lock n35 safety sleeve broke and the "whole system" detached from the needle.There were 2 occurrences reported with the same catalog and lot number.Individual date/time and or patient information is unknown.Investigation summary: a device history record review was performed for the provided lot number (1801114).The review did not reveal any documented quality issues during the production process that could have contributed to the reported incident.Investigation conclusion: as neither a physical sample nor a picture sample was available for return, five retained samples of the same lot number were obtained for investigation.Visual inspection of the retained samples did not reveal any defects.Each sample was engaged and disengaged several times with a protector product and no defects were observed.Root cause description: 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.If the grips of the safety sleeve become dislocated, the injector is activated causing needle exposure.To avoid damage to the safety sleeve grips, the injector must be removed by pulled it straight back and it cannot be forcefully engaged.It has been determined that this incident most likely occurred due to improper use.Rationale: complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that the bd phaseal¿ injector luer lock n35 safety sleeve broke and the "whole system" detached from the needle.There were 2 occurrences reported with the same catalog and lot number.Individual date/time and or patient information is unknown.

• 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
• 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: 8206863
• MDR Text Key: 131774959
• Report Number: 3003152976-2018-00565
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905150037
• UDI-Public: 30382905150037
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 515003
• Device Lot Number: 1801114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• 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