MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA INJECTOR (N35-O); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515052

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

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 needle became exposed when the outer membrane of the bd phaseal¿ optima injector (n35-o) stuck to the protector during disengagement.The following information was provided by the initial reporter: "while compounding a hazardous drug, the membrane and outer layer of the optima injector (n35-o) stuck to the vial protector and exposed the needle.".

Manufacturer Narrative

H.6.Investigation: one photo received for investigation, one optima injector hub connected to a syringe with the needle exposed was observed.Fifteen retained samples from the same lot were used for additional evaluation.No damage or other defects was observed on any of the product.Functional testing was performed, connecting the injector to a sample syringe, protector and vial according to the instructions for use.Each sample was tested ten times and each time there were no issues observed with the syringes and the injector.Issue observed by the customer (luer lock breakage) could not be replicated on none of retained samples and therefore the event reported could not be confirmed.Moreover, a short-term leakage test was performed on injector for 30 samples, no issues were found that could be involved in the incidence reported.No luer lock breakage nor broken injector safety sleeve was noticed.In all cases, the product functioned properly and there were no issues observed between the connection of the injectors and protector.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.A device history review was performed for the reported lot 2101309, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Testing results were reviewed for the reported lot and found all product met required specifications.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.H3 other text : see h.10.

Event Description

It was reported that the needle became exposed when the outer membrane of the bd phaseal¿ optima injector (n35-o) stuck to the protector during disengagement.The following information was provided by the initial reporter: "while compounding a hazardous drug, the membrane and outer layer of the optima injector (n35-o) stuck to the vial protector and exposed the needle.".

• Brand Name: BD PHASEAL OPTIMA INJECTOR (N35-O)
• 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: 12407189
• MDR Text Key: 269408583
• Report Number: 3003152976-2021-00536
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: K181221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

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 Expiration Date: 03/31/2022
• Device Catalogue Number: 515052
• Device Lot Number: 2101309
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1