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

Model Number 515005

Device Problems Break (1069); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: 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 bd phaseal¿ injector luer lock (n35c) experienced needle exposure, and device damage while still considered operable.The following information was provided by the initial reporter: when the injector was disengaged, the injector needle was exposed.Also, the connection interface between the spike set and the injector was deformed.A resident performed this operation and there might have been improper product handling.

Event Description

It was reported that the bd phaseal¿ injector luer lock (n35c) experienced needle exposure, and device damage while still considered operable.The following information was provided by the initial reporter: when the injector was disengaged, the injector needle was exposed.Also, the connection interface between the spike set and the injector was deformed.A resident performed this operation and there might have been improper product handling.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-02-18.H6: investigation summary: samples and photos received for investigation.Upon visual inspection, the injector was luer connected to a connector and the handles of the safety sleeve had slipped out of place, the needle was exposed and the connector had some damage to the head where it connects to the injector caused by an improper disconnection between the two components.Most probably caused by a misuse of the device during the connection/disconnection of the phaseal device against the mating component.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.The product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification and there is no damage to the product.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.It is important to follow the instructions for use when using phaseal devices to ensure the product functions properly.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12980623
• MDR Text Key: 285389541
• Report Number: 3003152976-2021-00810
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 50382905150055
• UDI-Public: 50382905150055
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 515005
• Device Catalogue Number: 515005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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