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	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, it is alleged that the surgeon's thumb went through the bottle when attempt to use.Customer was not sure how this happened whether surgeon was applying to much force is a possibility or maybe the cap wasn't punctured correctly when preparing.There was no harm to surgeon or patient.All plastic pieces were there accounted for and there was no break in sterility.
Additional Manufacturer Narrative
It was reported that the surgeon's thumb went through the bottle when attempt to use.There was no patient/user injury reported.Photo provided finds a crack visible in the middle of the bottle.A device history record review found no non-conformance's associated with this issue during production of this batch.Based on the available information, a definitive root cause could not be established.However, 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).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: 24378811
• Report Number: 1423507-2026-00031
• Device Sequence Number: 10279178
• Product Code: FQH
• UDI-Device Identifier: 00382909101102
• UDI-Public: (01)00382909101102(17)270228(10)5072319
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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: 5072319
• 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: 01/28/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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