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	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that when squeezing the surgiphor bottle, the surgeon's thumb broke straight through the plastic.There was no patient/user injury reported.A device history record review found no non-conformances associated with this issue during production of this batch.The subject device has been discarded and not available for evaluation.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.
Event or Problem Description
As reported, during a total knee replacement, the surgeon went to squeeze the surgiphor bottle as directed and when applied a little more pressure, it cracked and the thumb went through the bottle.A new bottle was provided and there was no patient/user injury reported.
Additional Manufacturer Narrative
It was reported that when squeezing the surgiphor bottle, the surgeon's thumb broke straight through the plastic.There was no patient/user injury reported.A device history record review found no non-conformances associated with this issue during production of this batch.The subject device has been discarded and not available for evaluation.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).Addendum: this supplemental mdr is submitted to update the imdrf b and g code.Updated fields: b4, g3, g6, h2, h6, h10.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, during a total knee replacement, the surgeon went to squeeze the surgiphor bottle as directed and when applied a little more pressure, it cracked and the thumb went through the bottle.A new bottle was provided and there was no patient/user injury reported.

• 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: 24341804
• Report Number: 1423507-2026-00029
• Device Sequence Number: 13239730
• Product Code: FQH
• UDI-Device Identifier: 00382909101102
• UDI-Public: (01)00382909101102(17)260331(10)4102060
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• 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): 02/27/2026

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 910110
• Device Lot Number: 4102060
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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