MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515078
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd infusion adapter c100-o had flow issues.The following information was provided by the initial reporter: material # 515078 batch # unknown verbatim: our biggest finding is as follows: we had a patient this week who came for the exact same medication 3 days in a row.The medication was prepared in a bd brand1000ml bag of dextrose 5% each time.Only 11ml of medication was added to this bag.1 nurse programmed the alaris pump at 1600ml total to run at 800ml/hr.There were no issues with leftover fluid/medication in the bag with air being sucked into the tube over fluid.Dose is to go in over an hour.This came out at approximately that.This nurse utilized a similar practice (way over volume and calculating an estimate for rate) and had no issues with fluid/air.A 2nd nurse programmed the alaris pump at 1040ml (the 1000ml, plus medication added, plus overfill) to run at 999ml per hour.Dose is to go in over an hour, but this is as high as the pump goes for rate.This nurse experienced the issue of air being pulled over fluid towards the end of her bag.She experienced this with all other medications she ran with a similar practice using phaseal optima and the alaris pumps.No issues if no phaseal.A 3rd nurse utilized the first nurse's practice today and ran the 1000ml bag in an alaris pump programed at 1600ml total to run at 800ml/hr.She experienced no issues.Customer response on (b)(6) 2026.We are now using bd bags for all of our infusions.Having started to use these bags, we are having difficulty with fluid/medication remaining in the bag, and the pump pulls air into the tubing instead of fluid/medication.We are seeing this in dextrose 5% and sodium chloride 0.9% bags in sizes 250ml, 500ml, and 1000ml bags.We have seen it across multiple lots of each.We are only seeing this for medications that have phaseal optima on the lines.Bags run through our alaris pumps without phaseal optima are not producing a problem.Our biggest finding is as follows: we had a patient this week who came for the exact same medication 3 days in a row.The medication was prepared in a bd brand1000ml bag of dextrose 5% each time.Only 11ml of medication was added to this bag.1 nurse programmed the alaris pump at 1600ml total to run at 800ml/hr.There were no issues with leftover fluid/medication in the bag with air being sucked into the tube over fluid.Dose is to go in over an hour.This came out at approximately that.This nurse utilized a similar practice (way over volume and calculating an estimate for rate) and had no issues with fluid/air.A 2nd nurse programmed the alaris pump at 1040ml (the 1000ml, plus medication added, plus overfill) to run at 999ml per hour.Dose is to go in over an hour, but this is as high as the pump goes for rate.This nurse experienced the issue of air being pulled over fluid towards the end of her bag.She experienced this with all other medications she ran with a similar practice using phaseal optima and the alaris pumps.No issues if no phaseal.A 3rd nurse utilized the first nurse's practice today and ran the 1000ml bag in an alaris pump programed at 1600ml total to run at 800ml/hr.She experienced no issues.
Additional Manufacturer Narrative
Investigation results: root cause couldn't be determined due to unavailability of sample information.A complaint history record (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record (dhr) review could not be performed as no batch/lot number was made available for this reported event.A review of the applicable risk document indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.
Event or Problem Description
No additional information.

• Brand Name: BD PHASEAL OPTIMA
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24741645
• Report Number: 3003152976-2026-00157
• Device Sequence Number: 13105705
• Product Code: ONB
• UDI-Device Identifier: 00382905150784
• UDI-Public: (01)00382905150784
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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 Catalogue Number: 515078
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown