MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SILICONE FLAT 7MM DRAIN JACKSON PRATT DRAIN; CATHETER, IRRIGATION

Catalog Number SU130-1310

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2020

Event Type  Injury  

Event Description

Jp drain removed from patient, health care provider felt a portion of drain retained.X-ray did not reveal the retained piece of jp drain.A ct scan was done and identified portion of jp drain.It was noted by radiologist that the jp drain was not sufficiently able to be visualized and that the manufacturer should enhance the product to be more x-ray detectable.Fda safety report id# (b)(4).

• Brand Name: SILICONE FLAT 7MM DRAIN JACKSON PRATT DRAIN
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC ; waukegan IL 60085
• MDR Report Key: 10108981
• MDR Text Key: 193704312
• Report Number: MW5094789
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2020

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 Catalogue Number: SU130-1310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR