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	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, multiple surgiphor bottles had busted in different specialties including plastics and spine.In plastics the bottle was leaking after setting it in on the table.In spine multiple bottles have busted in the hands of the surgeons while using it as a manual lavage.Reportedly, majority of the bottles are busting during use with the cap still intact.There was no patient or user injury reported.
Additional Manufacturer Narrative
As reported, multiple surgiphor bottles had busted in different specialties including plastics and spine.In plastics the bottle was leaking after setting it in on the table.In spine multiple bottles have busted in the hands of the surgeons while using it as a manual lavage.Based on the information available and without having the photos or sample to evaluate, no conclusions can be made.A device history record review found no non-conformances associated with this issue during production of the reported batch.Additionally, retain samples were inspected and found no visible abnormalities or signs of the reported cracking on the bottle.A capa was opened to investigate events of this nature.Complaints are monitored and reviewed for emerging trends.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 issue occurred with lot number 5156008.Additional mdrs were submitted for the issues reported to be occurred with lot number 5188215 and lot number 5090216 from the same facility.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 ; 8003239088
• MDR Report Key: 25555236
• Report Number: 1423507-2026-00087
• Device Sequence Number: 18383621
• Product Code: FQH
• UDI-Device Identifier: 00382909101102
• UDI-Public: (01)00382909101102(17)270430(10)5156008
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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: 5156008
• 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: 06/04/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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