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	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, it is alleged that the two surgiphor bottles (device 1 and 2) cracked during use.It was also reported that the representative present with the surgeon indicated that the bottles may have been opened incorrectly, which required him to apply excessive squeezing.There was no patient or user injury reported.This mdr represents surgiphor bottle (device #1).Additional mdr submitted to represent surgiphor bottle (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
As reported, it is alleged that the two surgiphor bottles (device 1 and 2) cracked during use.It was also reported that the representative present with the surgeon indicated that the bottles may have been opened incorrectly, which required him to apply excessive squeezing.There was no patient or user injury reported.
Additional Manufacturer Narrative
As reported, it is alleged that the two surgiphor bottles (device 1 and 2) cracked during use.It was also reported that the representative present with the surgeon indicated that the bottles may have been opened incorrectly, which required him to apply excessive squeezing.There was no patient or user injury reported.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 document the results of investigation performed to analyze the root cause.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.Updated fields: b4, g3, g6, h2, h6, h10.This supplemental mdr represents surgiphor bottle (device #1).Additional supplemental mdr submitted to represent surgiphor bottle (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
As reported, it is alleged that the two surgiphor bottles (device 1 and 2) cracked during use.It was also reported that the representative present with the surgeon indicated that the bottles may have been opened incorrectly, which required him to apply excessive squeezing.There was no patient or 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: 24512098
• Report Number: 1423507-2026-00036
• Device Sequence Number: 9960011
• Product Code: FQH
• UDI-Device Identifier: 00382909101102
• UDI-Public: (01)00382909101102(17)270228(10)5050076
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• 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): 03/24/2026

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: 5050076
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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