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	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the surgiphor bottle cracked during use.There was no patient/user injury.Evaluation of the returned sample finds a cracked bottle.A definitive cause of the cracked bottle could not be determined.A device history record review found no non-conformances associated with this issue during production of this batch.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.
Event or Problem Description
As reported, when surgeon squeezed the surgiphor bottle during total hip procedure, it cracked and leaked all over the gloves and gown.The surgery was proceeded with a new bottle.There was no patient/user injury.

• 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: 24341802
• Report Number: 1423507-2026-00028
• Device Sequence Number: 9912224
• 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): 01/28/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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