MAUDE Adverse Event Report: CAREFUSION, INC BD SURGIPHOR - SURGIRINSE

Model Number 910100

Device Problem Crack (1135)

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

Event Date 07/12/2022

Event Type  Injury  

Event Description

It was reported by the customer that the surgiphor bottle "exploded" while utilizing on tja.Verbatim: surgiphor bottle "exploded" while utilizing on tja.Hcp worried plastic could of fell into open incision.No patient harm, hcp worried about efficacy.

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Manufacturer Narrative

Photo and physical samples were received by our quality team 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 reported lot's (1854590) device history records were reviewed.All process and final inspections meet specifications.An in-depth investigation 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.This investigation is on-going as we continue to learn more about the probable root causes.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

It was reported by the customer that the surgiphor bottle "exploded" while utilizing on tja.Verbatim: surgiphor bottle "exploded" while utilizing on tja.Hcp worried plastic could of fell into open incision.No patient harm, hcp worried about efficacy.

• Brand Name: BD SURGIPHOR - SURGIRINSE
• Type of Device: BD SURGIPHOR - SURGIRINSE
• 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: 15174277
• MDR Text Key: 297325209
• Report Number: 1423507-2022-00015
• 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: Other,Company Representative
• Reporter Occupation: Physician
• 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 Expiration Date: 06/25/2023
• Device Model Number: 910100
• Device Catalogue Number: 910100
• Device Lot Number: 1854590
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 01/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other