MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA INFUSION ADAPTER (C100-0 MULTI); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515079
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/14/2020
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 2 bd phaseal optima infusion adapters (c100-0 multi) experienced leakage during use.The following information was provided by the initial reporter: i wanted to let you know that we¿ve had at least 2 instances in which the c100 has fallen out of the bag causing a chemo spill, most recently today.Both instances involved our regular pvc bags (not the pvc free, which also has had the c100 fall out).No the two instances i mentioned the bags were not were not refrigerated.One was a few weeks ago and that was a 500 ml ns bag.Today it happened on a ns 250 ml bag (ndc 338-0049-02, lot y33271 exp 8/21).I¿m not sure what lot/etc the c100 was from as the packaging was previously disposed of in another room.Additional info: currently we have the following in our compounding room: optima components c100-o bulk c100, lot 1910102, exp 09-30-2020, reference 515079.This complaint captures the event that occurred on 14-apr and the occurrence in the past on an unknown date.Additional information: both of my examples occurred within the pharmacy mixing area.In one instance the medication was being mixed inside the hazardous hood.The technician was adding cisplatin to the iv bag and the c100 fell out of the bag and we experienced a small chemotherapy spill inside of the hood.The second example the c100 became separated from the iv bag when after it was mixed and placed inside of a chemotherapy transport bag.Chemotherapy mixing was completed, final product was placed into the transport bag, and when the pharmacist went to add the second medication to that transport bag, the c100 had fallen off and chemotherapy was leaking inside of the transport bag.I have also had the c100 fall out of our pvc free bags when i was putting the final product into the transport bag.
Additional Manufacturer Narrative
H6: investigation summary no samples or pictures were received for the investigation.A device history review was conducted for lot number 1909105.20 retained samples from c100-o lot 1909105, 30 secondary iv sets, 15 baxter 500 ml iv bag and 15 fk 250 ml iv bag sodium chloride iv solution bags were requested for testing following the testing procedure included in the protocol issued.After testing, all samples meet acceptance criteria.Since no potential manufacturing issues were found, results from lot release testing on c100-o lot 1910102 meet acceptance criteria, the root cause cannot be established at this time.
Event or Problem Description
It was reported that 2 bd phaseal optima infusion adapters (c100-0 multi) experienced leakage during use.The following information was provided by the initial reporter: i wanted to let you know that we¿ve had at least 2 instances in which the c100 has fallen out of the bag causing a chemo spill, most recently today.Both instances involved our regular pvc bags (not the pvc free, which also has had the c100 fall out).No the two instances i mentioned the bags were not were not refrigerated.One was a few weeks ago and that was a 500ml ns bag.Today it happened on a ns 250ml bag (ndc 338-0049-02, lot y33271 exp 8/21).I¿m not sure what lot/etc the c100 was from as the packaging was previously disposed of in another room.Additional info: currently we have the following in our compounding room: optima components c100-o bulk c100 lot 1910102 exp 09-30-2020 reference 515079 this complaint captures the event that occurred on 14-apr and the occurrence in the past on an unknown date.Additional information: both of my examples occurred within the pharmacy mixing area.In one instance the medication was being mixed inside the hazardous hood.The technician was adding cisplatin to the iv bag and the c100 fell out of the bag and we experienced a small chemotherapy spill inside of the hood.The second example the c100 became separated from the iv bag when after it was mixed and placed inside of a chemotherapy transport bag.Chemotherapy mixing was completed, final product was placed into the transport bag, and when the pharmacist went to add the second medication to that transport bag, the c100 had fallen off and chemotherapy was leaking inside of the transport bag.I have also had the c100 fall out of our pvc free bags when i was putting the final product into the transport bag.

• Brand Name: BD PHASEAL OPTIMA INFUSION ADAPTER (C100-0 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: 10027224
• Report Number: 3003152976-2020-00187
• Device Sequence Number: 2714972
• Product Code: ONB
• UDI-Device Identifier: 00382905150791
• UDI-Public: 00382905150791
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (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): 11/18/2020

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: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 515079
• Device Lot Number: 1910102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other