MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P20-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515064
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material# 515064.Batch# 2404403.It was reported by customer that the drug being used doxorubicin is coming up at the top verbatim: rcc received a complaint via phone.Pir attached productcomplaint - customer called to report that while using the phaseal product: ref (b)(4), lot 2404403, the drug being used doxorubicin is coming up at the top.Sample discarded, no exposure or injury to pt and health care professional.Picture samples available.Doe (b)(6) 2024.
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.
Event or Problem Description
Material# 515064 batch# 2404403.It was reported by customer that the drug being used doxorubicin is coming up at the top rcc received a complaint via phone.Pir attached product complaint - customer called to report that while using the phaseal product: ref 515064, lot 2404403, the drug being used doxorubicin is coming up at the top.Sample discarded, no exposure or injury to pt and health care professional.Picture samples available.Doe (b)(6)2024.Per message from rep: essentially chemotherapy (doxorubicin) was present on the top (of the membrane of the p20 -protector) when the needle was removed.My technician blotted the spot to show the red colored drug.No patient harm, injury, complication or negative outcome.No staff harm either.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: both photos and one unused sample was provided to our quality team for investigation.Through initial evaluation of the photo, the membranes are observed to have been punctured and a reddish color can be seen on the membrane.Functional testing was performed on the returned sample, after passing liquid through the system and disconnecting the injector from the protector, no liquid or evidence of a leak was observed.Additional leakage testing was performed, penetrating the membrane ten times.In all cases the product functioned as intended and no leakage was observed.A device history review was performed for lot 2404403, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Leakage and pressure testing is performed for all lots during manufacturing to ensure the quality of the membrane.Results were reviewed for returned lot 2404403, and all results were found to be acceptable.Three retained samples of the reported lot were used for additional evaluation.The membranes were punctured up to ten times, in all cases the product functioned as intended and no leakages occurred.The performance of the sealing membrane is reduced after multiple perforations and extended activation time, the membranes are designed to be punctured up to ten times.Based on the sample evaluation and quality team's investigation, we cannot identify a root cause related to our process at this time.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 P20-O
• 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 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20258341
• Report Number: 3003152976-2024-00513
• Device Sequence Number: 7886473
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: (01)00382905150647(11)240422(17)260331(10)2404403
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• 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): 01/03/2025

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: 03/31/2026
• Device Catalogue Number: 515064
• Device Lot Number: 2404403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown