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

Model Number 910100

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2023

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(4) initial mdr.A follow up will be submitted if additional information becomes available.Procode: fqh (lavage, jet) and fro (dressing, wound, drug).

Event Description

It was reported that a surgiphor iodine bottle cracked.

Manufacturer Narrative

Pr 7483583 supplemental mdr.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.Section d.2b procode: fqh (lavage, jet) and fro (dressing, wound, drug) h3 other text : see narrative below.

Event Description

It was reported that a surgiphor iodine bottle cracked.

• 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 Key: 16701507
• MDR Text Key: 313326155
• Report Number: 1423507-2023-00088
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00382909101003
• UDI-Public: (01)00382909101003
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K202071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2023
• Device Model Number: 910100
• Device Catalogue Number: 910100
• Device Lot Number: 1862098
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1