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U.S. Department of Health and Human Services

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

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CAREFUSION, INC BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM Back to Search Results
Model Number 910100
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2022
Event Type  malfunction  
Manufacturer Narrative
No photos or samples were received for evaluation.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 sugiharas 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.Fqh (lavage, jet) and fro (dressing, wound, drug).
 
Event Description
It was reported by the customer that 3 bottles of surgiphor cracked during use.
 
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Brand Name
BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM
Type of Device
SURGIPHOR
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
8015652341
MDR Report Key16147884
MDR Text Key308393611
Report Number1423507-2023-00027
Device Sequence Number1
Product Code FQH
UDI-Device Identifier00382909101003
UDI-Public(01)00382909101003
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K202071
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/12/2023
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
Device Operator Health Professional
Device Expiration Date08/02/2023
Device Model Number910100
Device Catalogue Number910100
Device Lot Number1859215
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2022
Initial Date FDA Received01/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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