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

Catalog Number 515008

Device Problems Difficult or Delayed Activation (2577); Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one injector sample was provided to our quality team for investigation.The product was visually inspected no issues were noted on the membrane of the injector, however, the grips of the safety sleeve were observed to be moved from their original place which lead to the needle becoming exposed.The sample was functionally tested, resistance was noted when attempting to aspirate liquid from the vial.The injector was further evaluated and found the needle of the injector was partially clogged by a polypropylene particle.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including flow rate verification.As a lot number was unavailable for this incident, a device history record review could not be completed and additional retained samples could not be investigated.While we cannot identify a direct issue, this failure can occur due to improper positioning of the cannula when inserted into the needle housing which may result in the polypropylene becoming pulled into the cannula and creating an occlusion.Without the lot code to review the device records, this cannot be verified for the product that was reported.Manufacturing personnel have been notified of this incident to increase awareness.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that the bd phaseal" injector luer lock n35j safety sleeve had moved and exposed the needle.Additionally, foreign polypropylene had partially clogged the needle.The following information was provided by the initial reporter, translated from (b)(6) to english: "during preparation of an anticancer agent (epirubicin) by using injector attaching to a syringe, the hcp felt strong resistance in aspirating and injecting, which he/she had never felt in usual operation procedures." per rep: the customer connected syringe to n35 after filled air into syringe.(vial is liquid medication) then the customer connected n35 to protector.And plunger was pushed.Then resistance was found though not occluded.Even if there was difficulty, the customer managed to do mixing and it was done successfully." via bd investigation: "the grips of the safety sleeve were observed to be moved from their original place which lead to the needle becoming exposed.The sample was functionally tested, resistance was noted when attempting to aspirate liquid from the vial.The injector was further evaluated and found the needle of the injector was partially clogged by a polypropylene particle.".

• Brand Name: BD PHASEAL INJECTOR LUER LOCK N35J
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12271332
• MDR Text Key: 265210750
• Report Number: 3003152976-2021-00447
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• 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