MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SILICONE FLAT DRAIN JP 7MM; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Lot Number 1211291

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/29/2023

Event Type  Injury  

Event Description

Two jp drains were removed.One was removed intact, but the second jp drain broke and a piece was retained.Both are available for evaluation.Reference report mw5116307, mw5116308, mw5116309.

• Brand Name: SILICONE FLAT DRAIN JP 7MM
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 16682751
• MDR Text Key: 312822336
• Report Number: MW5116310
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/31/2023

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 Lot Number: 1211291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Hispanic
• Patient Race: White