MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P14; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material# 515100 batch# unknown.It was reported by customer that leak out of the top of the bottle between the protector and the bottle verbatim: rcc received a complaint via email.Email(s) attached.Full name: (b)(6).Are you a healthcare provider? no.Specialty: pharmaceuticals.Specialty other: n/a.Hospital/organization: amatheon animal health department: purchasing state: (b)(6).Postal code: (b)(6).Country: united states phone number: (b)(6).Phone extension: (b)(6).Email address: (b)(6).Inquiry topic: faulty phaseal 515100 inquiry details: on (b)(6) 2024, (b)(6) was opening a new bottle of mitoxantrone for a treatment.She added the phaseal satellite/protector top to the bottle, and was able to start drawing up the medication, but partway through, pressure seemed to build up and mito spilled out of the bottle, dripping onto the mats in the hood and spraying onto (b)(6) chemo gown.It seemed to leak out of the top of the bottle between the protector and the bottle.She did not report anything abnormal leading up to the chemo spill.I saved the bottle of chemo with the phaseal protector attached as well as the packaging for both if we need to send it in for quality control reporting.If not, let me know and i will dispose of them.Product name: phaseal protector p14 closed system transfer device sku: 515100.Additional informattion: please share the lot number? -  lot # 2309110.  2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.- there was no bodily harm but the chemo leaked out of the bottle which could have exposed me to the chemotherapy had i not been wearing ppe.The phaseal system in theory should keep me safe from any chemo exposure which it failed to do.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: no samples or photos were received for investigation.A device history review was performed for lot 2309110, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples from the same lot were used for further evaluation.The protectors were successfully connected to the vials, ensuring that they fit correctly.The product was evaluated, and no damage or defects were observed.Functional tests were performed on the samples and no leakage was identified between the protector and the vial.The product undergoes visual and functional testing throughout manufacturing, including leak testing.Results were reviewed for lot 2309110 and found no problems related to the reported event.Based on the available information, we are unable to identify a root cause related to the manufacturing process at this time.It is possible the protector was not properly attached, resulting in the leak reported.The protector must be attached completely vertical to the vial during assembly.The m12 assembly fixture is recommended to ease the connection of the protector to the vial and must be used in a slow and consistent motion.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: PROTECTOR P14
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 19242004
• Report Number: 3003152976-2024-00265
• Device Sequence Number: 18016107
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: (01)00382905151002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

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: 515100
• Device Lot Number: 2309110
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 09/03/2024
• 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