MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P13-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515060
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11 -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
Description: it was reported by customer precipitant in the bag.Event details: today we have had several issues with precipitants and plastics in the bags.We had a total of (b)(4) 200 mg keytruda bags ((b)(6) a piece), (b)(4) 1500 mg imfinzi bag ((b)(6)) and (b)(4) 420 mg perjeta bags ((b)(6) a piece).We also had (b)(4) keytruda vials ((b)(6)) that have precipitant after the vial was spiked with vial adapters (lot#2410402).However, when we troubleshot the compounding of one of our keytruda bags, we injected keytruda only with needles and spiked the secondary set, but we still had precipitation in the bag.The bag spike lot # 2405504.We're just grasping at straws to figure out why this occurred.Additional information: it is very difficult to see but it looks like microparticles suspended in solution.Could be drug or air bubbles, but i want it tested to be safe.
Additional Manufacturer Narrative
Pr 12460779 follow up mdr for device evaluation: one photograph and four vials were provided to the quality team for investigation.Upon evaluation, no particles or other foreign matter were identified in the submitted photograph or within the returned vials.A device history record review was conducted for protector lot 2410402 and adapter lot 2405504.No deviations or nonconformances were identified during manufacturing that could have contributed to the reported concern.In addition, retained samples from each lot were evaluated.Visual inspection revealed no defects, and fragmentation testing confirmed that all products met applicable specifications.Based on the results of the investigation, the reported condition could not be confirmed; therefore, a root cause could not be established at this time.We appreciate you bringing this observation to our attention.Complaints related to this device and reported condition will continue to be tracked and trended.Data will be captured in trend reports and reviewed on a monthly basis as part of our routine quality monitoring to identify any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: PROTECTOR P13-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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22636658
• Report Number: 3003152976-2025-00393
• Device Sequence Number: 8155124
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: (01)00382905150609(11)241004(17)260930(10)2410402
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/22/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 515060
• Device Lot Number: 2410402
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown