FOREIGN BODY RETRIEVAL HOOD PROTECTOR 69392

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for FOREIGN BODY RETRIEVAL HOOD PROTECTOR 69392 manufactured by Haylard Belgium Bv Bh/avanos Medical Inc..

Event Text Entries

[127347671] During an upper endoscopy for foreign body retrieval in the micu, there was device failure four times. The device was the halyard foreign body retrieval hood protector. One device tore during placement on the endoscopy, two failed to deploy as expected, one was sealed shut and could not be installed on the endoscope and appeared to be due to degradation of the device material, which made them too flexible to be usable. An alternative device with another brand was then installed on the endoscope and worked properly as expected, the first time. The device failures resulted in significant delay in completion of the procedure. A (b)(6)-yo with no pmhx who presents to inpatient with si and a history of swallowing numerous objects. He now reports having swallowed a safety pin. No surgical abdomen. # ingestion - stat portable chest/abdomen x-ray demonstrates safety pin in stomach - consultation with gi fellow on call, pt requires stat transfer to (b)(6) for egd removal, coordinating with accepting medicine service.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5081265
• MDR Report Key: 8071074
• Date Received: 2018-11-13
• Date of Report: 2018-11-06
• Date of Event: 2018-10-17
• Date Added to Maude: 2018-11-14
• 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: 1

• Brand Name: FOREIGN BODY RETRIEVAL HOOD PROTECTOR
• Generic Name: ENDOSCOPIC ACCESS OVERTUBE GASTROENTEROLOGY
• Product Code: FED
• Date Received: 2018-11-13
• Catalog Number: 69392
• Lot Number: M18256E203
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HAYLARD BELGIUM BV BH/AVANOS MEDICAL INC.
• Manufacturer Address: ALPHARETTA GA 30004 US 30004

Device Sequence Number: 2

• Brand Name: FOREIGN BODY RETRIEVAL HOOD PROTECTOR
• Generic Name: ENDOSCOPIC ACCESS OVERTUBE GASTROENTEROLOGY
• Product Code: FED
• Date Received: 2018-11-13
• Lot Number: M7170E201
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: HAYLARD BELGIUM BV BH/AVANOS MEDICAL INC.
• Manufacturer Address: ALPHARETTA GA 30004 US 30004

Device Sequence Number: 3

• Brand Name: FOREIGN BODY RETRIEVAL HOOD PROTECTOR
• Generic Name: ENDOSCOPIC ACCESS OVERTUBE GASTROENTEROLOGY
• Product Code: FED
• Date Received: 2018-11-13
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: HAYLARD BELGIUM BV BH/AVANOS MEDICAL INC.
• Manufacturer Address: ALPHARETTA GA 30004 US 30004

Device Sequence Number: 4

• Brand Name: FOREIGN BODY RETRIEVAL HOOD PROTECTOR
• Generic Name: ENDOSCOPIC ACCESS OVERTUBE GASTROENTEROLOGY
• Product Code: FED
• Date Received: 2018-11-13
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: HAYLARD BELGIUM BV BH/AVANOS MEDICAL INC.
• Manufacturer Address: ALPHARETTA GA 30004 US 30004

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-11-13