MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC UNKNOWN PRODUCT-MED; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number UNKNOWN PRODUCT-MED

Device Problem Break (1069)

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

Event Date 10/13/2022

Event Type  Injury  

Manufacturer Narrative

As no lot number was provided, we were unable to trace the device history record dhr, quality testing performed and corresponding results.The non-comformance report ncr data since (b)(6) 2019 to present was reviewed and no issues that could be related to the catalog and condition reported.The customer sample was not available for evaluation.Photo was received for investigation which showed a jackson pratt drain.Condition reported could not be confirmed using a photo.Root cause for the reported concern cannot be identified with the information provided.It is recommended to strictly follow the instructions provided in the instruction for use (ifu) data included with the product to ensure drains are properly used.As preventive actions, the customer will be provided with a copy of the instructions for use.No further action is planned at this time.

Event Description

From the medwatch report mw5112753, customer reported the jp (jackson-pratt) drain was placed in patient then removed a few days later in (b)(6) 2022.During the removal process, the drain snapped and broke the tubing.A small piece of the drainage tubing end was left in the patient.Drain tubing fragment was then removed at the bedside.No further injury or further information was reported.

• Brand Name: UNKNOWN PRODUCT-MED
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15849819
• MDR Text Key: 304174959
• Report Number: 1423537-2022-00864
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PRODUCT-MED
• Device Catalogue Number: UNKNOWN PRODUCT-MED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 64 KG