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	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that 2-3 surgiphor bottles have broken a few times at the site.No photos or samples were received for investigation; therefore, the root cause could not be determined.Note, the date of event (15-dec-2025) is considered to be a best estimate.This mdr represents surgiphor bottle (device #3).Additional mdrs were submitted to represent surgiphor bottles (device #1 and device #2) 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
It was reported that 2-3 surgiphor bottles have broken a few times at the site.
Additional Manufacturer Narrative
It was reported that 2-3 surgiphor bottles have broken a few times at the site.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).Addendum: h11: this supplemental mdr is submitted to document the results of investigation performed to analysis root cause.A video sent in shows health care professional demonstrating cracking of bottle.Based on the investigation activities performed and analysis of the video provided, the reported cracked bottle has been confirmed.A device history record could not be evaluated as the lot number is unknown.A capa was opened to investigate events of this nature.Complaints are monitored and reviewed for emerging trends.Note, the date of event (01-dec-2025) is considered to be a best estimate.Updated fields: b4, g3, g6, h2, h6, h10, h11.Corrected fields: b5, b4.This supplemental mdr represents surgiphor bottle (device #3).Additional supplemental mdrs were submitted to represent surgiphor bottles (device #1 and device #2).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
It was reported that 2-3 surgiphor bottles have broken a few times at the site.Video sent in shows health care professional demonstrating cracking of bottle.

• 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: 23962298
• Report Number: 1423507-2025-00191
• Device Sequence Number: 20036138
• Product Code: FQH
• UDI-Device Identifier: 00382909101102
• UDI-Public: (01)00382909101102
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: UNKNOWN
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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