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	08/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d 2b pro codes: fqh (lavage, jet) and fro (dressing, wound, drug) a photo of the cracked incident was received by our quality team for evaluation.The returned photo was visually inspected at becton dickinson and the cracked incident could be verified.The reported lot's (1854588) 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.
Event or Problem Description
Two surgiphor's burst while being used in surgery, causing the betadine to splash all over the surgeon and scrub tech no impact on patient; surgeon used the surgiphor until it burst.When pressure was applied, the surgiphor bottles burst in the middle of the bottle.
Additional Manufacturer Narrative
Update made to the sections titled 'device returned to manufacturer' and 'device eval by manufacturer' (device manufacturers only (h)) h3 other text : see narrative below.
Event or Problem Description
It was reported by the customer that they had two surgiphor packages with visible leaking within the sterile packaging; two burst while being used in surgery.Verbatim: two surgiphor packages had visible leaking within the sterile packaging.Two surgiphor's burst while being used in surgery, causing the betadine to splash all over the surgeon and scrub tech.No impact on patient; surgeon used the surgiphor until it burst; leaking surgiphor packages were not used.When pressure was applied, the surgiphor bottles burst in the middle of the bottle (please see attached photo).Additionally, there were two individual surgiphor packages that were visibly leaking within the sterile packaging (please see attached photo).Those were thrown away and replaced.

• 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: 16154725
• Report Number: 1423507-2023-00046
• Device Sequence Number: 7507765
• Product Code: FQH
• UDI-Device Identifier: 00382909101003
• UDI-Public: (01)00382909101003
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 01/27/2023

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 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
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 01/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown