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

Catalog Number 515052

Device Problem Volume Accuracy Problem (1675)

Patient Problem Swelling (2091)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1908105, medical device expiration date: 2020-07-31, device manufacture date: 2019-08-27, medical device lot #: 1907104, medical device expiration date: 2020-02-29, device manufacture date: 2019-07-17.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 an unspecified number of bd phaseal optima injectors (n35-o) experienced volumetric inaccuracies upon disengagement.Product defect was noted during use.The following information was provided by the initial reporter: material no.515052, batch no.1908105, 1907104.Information learned from lead pharmacy technician representing eight pharmacy technicians during the 30 day post conversion meeting.Background: site began using phaseal, (b)(6) 2010.No voiced or documented ergonomic concerns with using phaseal preparations volume : 85 pts.A day at 2.5 doses averaged per patient this was quoted by pharmacist manager = 212 doses a day or 552, 50 doses a year.Lead pharmacy technician detailed the ergonomic concern when moving from phaseal to optima (b)(6), 2019.Difficult to disengage injectors from protector, injectors from infusion adapter resulting in experiencing sore shoulders and neck and thumbs.Degree of difficulty to disengage noticeable more than when preparing with phaseal verbalized by all nine pharmacy technicians.All pharmacy technicians have mentioned the difficulty to disengage and with repetitive preparations resulting in soreness during and at end of day all pharmacy technicians mentioned the degree of soreness, was not displayed when working with bd phaseal at the end or during the day.Product performance: with most syringes but mostly using the 50 cc syringe with optima the desired dose was withdrawn with injectors / protector in upright, position then vial placed flat on surface biological safety cabinet to disengager.The result a miss with the volumes of desired dose.I asked how the injectors to protector disengagement was occurring and the answers were upright, also vial flat to surface and vial horizontal to surface.I asked to better understand the techniques, when using phaseal injectors/protector unit disengaged from vial, when vial was flat to surface or vial upright resulting i resulting desired drug volume in syringe.The pharmacy technician stated it "with this steps using optima the desired drug is visualized however the volumes shift to less than what was visualized when the injectors and protector unit are disengaged., result going back-into vial to withdraw the desired hd dose, so extra steps used when preparing with optima versus phassal.".

Manufacturer Narrative

After further evaluation due to additional information mfr#3002682307-2020-00122 has been deemed not reportable.Inadequate pressure equalization related to user error resulting in negative pressure inside the syringe can result in reduced volume inside they syringe.This would be an inconvenience as an additional step would be required to obtain the remaining medication but not would not lead to harm or serious injury.Mfr#3002682307-2020-00122 is void as a result.

Event Description

It was reported that an unspecified number of bd phaseal optima injectors (n35-o) experienced volumetric inaccuracies upon disengagement.Product defect was noted during use.The following information was provided by the initial reporter: material no.515052 batch no.1908105, 1907104.Information learned from lead pharmacy technician representing eight pharmacy technicians during the 30 day post conversion meeting background: site began using phaseal , november 2010.No voiced or documented ergonomic concerns with using phaseal.Preparations volume : 85 pts.A day at 2.5 doses averaged per patient this was quoted by pharmacist manager = 212 doses a day or 552, 50 doses a year.Lead pharmacy technician detailed the ergonomic concern when moving from phaseal to optima december, 2019.Difficult to disengage injectors from protector, injectors from infusion adapter resulting in experiencing sore shoulders and neck and thumbs.Degree of difficulty to disengage noticeable more than when preparing with phaseal verbalized by all nine pharmacy technicians.All pharmacy technicians have mentioned the difficulty to disengage and with repetitive preparations resulting in soreness during and at end of day.All pharmacy technicians mentioned the degree of soreness, was not displayed when working with bd phaseal at the end or during the day.Product performance: with most syringes but mostly using the 50 cc syringe with optima the desired dose was withdrawn with injectors / protector in upright, position then vial placed flat on surface biological safety cabinet to disengage.The result a miss with the volumes of desired dose.I asked how the injectors to protector disengagement was occurring and the answers were upright, also vial flat to surface and vial horizontal to surface.I asked to better understand the techniques , when using phaseal injectors/protector unit disengaged from vial, when vial was flat to surface or vial upright resulting i resulting desired drug volume in syringe.The pharmacy technician stated it "with this steps using optima the desired drug is visualized however the volumes shift to less than what was visualized when the injectors and protector unit are disengaged., result going back-into vial to withdraw the desired hd dose, so extra steps used when preparing with optima versus phassal.".

• Brand Name: BD PHASEAL OPTIMA INJECTOR (N35-O)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 9918526
• MDR Text Key: 225478379
• Report Number: 3002682307-2020-00122
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515052
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other