MAUDE Adverse Event Report: CARDINAL HEALTH 200, INC. JACKSON-PRATT; CHANNEL DRAIN

Catalog Number CAT. JP-2190

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 04/19/2014

Event Type  No Answer Provided  

Event Description

Five days post op from open gastric bypass surgery, during removal of jackson-pratt drain, an end portion of the drain fractured and was retained intra-abdominally.The patient was taken back to surgery for removal of retained piece of drain.

• Brand Name: JACKSON-PRATT
• Type of Device: CHANNEL DRAIN
• Manufacturer (Section D): CARDINAL HEALTH 200, INC.; 1500 waukegan road; mcgaw park IL 60085
• MDR Report Key: 3889982
• MDR Text Key: 4653918
• Report Number: 3889982
• Device Sequence Number: 1
• Product Code: GCY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/22/2014

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?: *
• Device Operator: Physician
• Device Catalogue Number: CAT. JP-2190
• Device Lot Number: P1323390
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2014
• Patient Sequence Number: 1
• Patient Age: 63 YR