MAUDE Adverse Event Report: CareFusion, Inc BD Surgiphor¿ Sterile Wound Irrigation System

Catalog Number	910110
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a orthopedic procedure surgiphor bottle was cracked.The bottles were handed off successfully to the field without damage, but when the surgeon tried to use the product the bottle broke.Reportedly, "the bottles were very brittle and basically broke while being used." it was also reported that the product was stored at room temperature in the core prior to use and the cracked bottle fragments were contained and discarded.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, during a orthopedic procedure when the surgeon tried to use the product the surgiphor bottle cracked.Reportedly, "the bottles were very brittle and basically broke while being used." there was no reported patient injury.Based on the representative photo provided, the reported event has been confirmed.However, a definitive cause of the cracked bottle could not be determined.Section c.1a name and strength: 0.5% povidone iodine (pvp-i) in phosphate-buffered saline, potassium iodide, and vitamin e tpgs.Section d.2b procode: fqh (lavage, jet) and fro (dressing, wound, drug).This mdr represents surgiphor bottle (device #2).Additional mdrs were submitted to represent surgiphor bottle (device #1, #3 & #4).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BD Surgiphor¿ Sterile Wound Irrigation System
• Common Device Name: Surgiphor
• Manufacturer (Section D): CareFusion, Inc; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CareFusion, Inc; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: andrew topoulos ; 75 north fairway drive; vernon hills, IL 60061 ; +1(800)323-9088
• MDR Report Key: 50150043
• Report Number: 1423507-2026-00118
• Device Sequence Number: 13405893
• Product Code: FQH
• UDI-Device Identifier: 00382909101102
• UDI-Public: (01)00382909101102(17)270531(10)5230392
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K221504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 910110
• Device Lot Number: 5230392
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown