MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA INJECTOR (N40-O MULTI); INTRAVASCULAR ADMINISTRATION SET

Model Number	515057
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a small piece of loose "membrane" was found atop the bd phaseal¿ optima injector (n40-o multi) during use.This complaint was created to capture the 1st of 4 related incidents.The following information was provided by the initial reporter: "pharmacy noticed tiny piece (grain of sand size) of loose membrane material (or something?) sitting on top of p20-o phaseal optima protector membrane when disconnecting the injector after drawing up drug.I, the rep saw it too.This happened 4 times.All the injectors came from the same multipack package etoposide ¿ tiny piece of membrane observed on top of c100 protector membrane after drawing up medication.Irinotecan ¿ 4 vials.Protector and injector on vial #4 have small visible holes from injector needle.Again, a tiny piece of membrane observed on top of protector membrane.Velcade ¿ subq syringe.Again, a tiny piece of membrane observed on top of protector membrane.Alimta ¿ 5 vials / reconstituted powder.First access to diluent bottle had a tiny piece of membrane observed on top of protector membrane.Adapter membrane on bag had a lot of shine after drug was added with the injector that had been engaged 6 times at this point.".
Additional Manufacturer Narrative
Investigation summary: three photos which display the protector attached to a vial were provided to our quality team for investigation.Upon visually inspecting the photos, no fragments or shine can be observed on the membrane of the product.A device history review was performed for lot protector lots 2103406 and 2101402, along with injector lot 2010801, no deviations or non-conformances were identified during the manufacturing process that could have contributed to these issues.Fragmentation testing is performed during manufacturing to evaluate any particulates generated after ten activations.Testing results were reviewed for the reported lot and results were found to be acceptable.Four retained samples of each reported lot were used for additional evaluation.The product was visually inspected and no defects were observed on any of the product.Functional testing was also performed, penetrating the protectors from lot 2101402 and 2103406 with sample injectors from lot 2010801 ten times.In all cases the product functioned as intended and no fragmentation was identified.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.Complaints received for this device and reported defect will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported that a small piece of loose "membrane" was found atop the bd phaseal¿ optima injector (n40-o multi) during use.This complaint was created to capture the 1st of 4 related incidents.The following information was provided by the initial reporter: "pharmacy noticed tiny piece (grain of sand size) of loose membrane material (or something?) sitting on top of p20-o phaseal optima protector membrane when disconnecting the injector after drawing up drug.I, the rep saw it too.This happened 4 times.All the injectors came from the same multipack package - etoposide ¿ tiny piece of membrane observed on top of c100 protector membrane after drawing up medication.Irinotecan ¿ 4 vials.Protector and injector on vial #4 have small visible holes from injector needle.Again, a tiny piece of membrane observed on top of protector membrane.Velcade ¿ subq syringe.Again, a tiny piece of membrane observed on top of protector membrane.Alimta ¿ 5 vials / reconstituted powder.First access to diluent bottle had a tiny piece of membrane observed on top of protector membrane.Adapter membrane on bag had a lot of shine after drug was added with the injector that had been engaged 6 times at this point.".

• Brand Name: BD PHASEAL OPTIMA INJECTOR (N40-O MULTI)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12140351
• Report Number: 3003152976-2021-00375
• Device Sequence Number: 14450129
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: 00382905150579
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 515057
• Device Catalogue Number: 515057
• Device Lot Number: 2010801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1