COOK MEDICAL G55723 CPPD850IMH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-22 for COOK MEDICAL G55723 CPPD850IMH manufactured by Cook Medical.

Event Text Entries

[60925791] During chest tube insertion the tip of the chest tube sheared/broke off into the baby's pleural space. Unsure of cause. Provider does not describe any difficulty with insertion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5066291
• MDR Report Key: 6127144
• Date Received: 2016-11-22
• Date of Report: 2016-11-22
• Date of Event: 2016-11-17
• Date Added to Maude: 2016-11-25
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: COOK MEDICAL
• Generic Name: PNEUMOPERICARDIAL DRAINAGE SET
• Product Code: GBX
• Date Received: 2016-11-22
• Model Number: G55723
• Catalog Number: CPPD850IMH
• Lot Number: 5158543
• Device Expiration Date: 2016-07-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: COOK MEDICAL
• Manufacturer Address: BLOOMINGTON IN 47404 US 47404

Device Sequence Number: 1

• Brand Name: COOK MEDICAL
• Generic Name: PNEUMOPERICARDIAL DRAINAGE SET
• Product Code: PPD
• Date Received: 2016-11-22
• Model Number: G55723
• Catalog Number: CPPD850IMH
• Lot Number: 5158543
• Device Expiration Date: 2016-07-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOK MEDICAL
• Manufacturer Address: BLOOMINGTON IN 47404 US 47404

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2016-11-22