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

Catalog Number 910110

Device Problem Crack (1135)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

The surgiphor bottle exploded while the cap was being screwed on.

Manufacturer Narrative

(b)(4) initial mdr.A follow up will be submitted if additional information becomes available.--- section d.2b procode: fqh (lavage, jet) and fro (dressing, wound, drug).

Manufacturer Narrative

(b)(4)supplemental mdr.One photo was received by our quality team for evaluation.From the photo, the bottle was observed to be cracked around the top cap area confirming the customer¿s experience.A device history record could not be evaluated as the lot number is unknown.The most probable root cause can be attributed to post manufacturing handling.During shipment, boxes may be dropped or impacted which can be excessive handling causing the leakage.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.---- section d.2b procode: fqh (lavage, jet) and fro (dressing, wound, drug) h3 other text : see narrative below.

Event Description

The surgiphor bottle exploded while the cap was being screwed on.

• 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 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: andrew topoulos ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17939661
• MDR Text Key: 325735270
• Report Number: 1423507-2023-00102
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00382909101102
• UDI-Public: (01)00382909101102
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K221504
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 910110
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1