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 08/02/2022

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 307938232
• Report Number: 1423507-2023-00046
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 910100
• Device Catalogue Number: 910100
• Device Lot Number: 1854588
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 01/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1