MAUDE Adverse Event Report: CAREFUSION, INC BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

Model Number	910100
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Another surgiphor bottle busted during a tka.
Additional Manufacturer Narrative
Pro codes: fqh (lavage, jet) and fro (dressing, wound, drug).Physical samples were received for evaluation.The returned complaint samples were visually inspected at becton dickinson.The cracks with the surgiphor containers were observed to all occur at the same general location.All of the complaint samples had a crack on the same side of the surgiphor container, near the embossed ¿s¿ of ¿surgiphor¿ at the top or bottom of the container.More specifically, the crack is always present at the upper edge or the lower edge of the area designed as a hand grip.These complaint samples were then evaluated using computerized tomography (ct) scanning.The ct testing demonstrated that cracks within the surgiphor container was observed to occur in the same general location of the container.The lot device history records were reviewed.All process and final inspections meet specifications.A capa has been opened for this issue.An in-depth investigation as part of that capa has been performed to identify the cause of the surgiphor bottle cracking during use.At this time this investigation discovered that the combination of the following variables are probable causes that contribute to the failure mode of surgiphor containers cracking during use: aging, bottle wall thickness/bottle weight, inspected product returned into the manufacturing lot, and upper end of the gamma sterilization dosages of the product.A follow-up will be sent if additional information is received.

• 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 16154728
• Report Number: 1423507-2023-00048
• Device Sequence Number: 15216751
• Product Code: FQH
• UDI-Device Identifier: 00382909101003
• UDI-Public: (01)00382909101003
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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: 06/24/2023
• Device Model Number: 910100
• Device Catalogue Number: 910100
• Device Lot Number: 1854588
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown