ENTERAL ADMINISTRATION Y-ADAPTER SET 14-9215 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-04-16 for ENTERAL ADMINISTRATION Y-ADAPTER SET 14-9215 UNKNOWN manufactured by Biosearch.

Event Text Entries

[187] The enteral administration y-adapter set used in tube feed strecthes. The attached plug does not fit tightly, thus when gastric pressure builds up, the plug pops out allowing gastric contents to flow from the tube causing severe burns to patients. The manufacturer was notified and replaced the y-adapter set with twin-port universal y-adapterdevice labeled for single use. Patient medical status prior to event: fair condition. There was multiple patient involvement. Number of patients involved: 2. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: other, other, other, invalid data. Results of evaluation: invalid data, invalid data, invalid data, invalid data. Conclusion: device failed during assembly, device failed during assembly, other, other. Certainty of device as cause of or contributor to event: yes. Corrective actions: use of all similar devices stopped permanently, invalid data, invalid data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 396
• MDR Report Key: 396
• Date Received: 1992-04-16
• Date of Report: 1992-03-31
• Date of Event: 1992-03-28
• Date Facility Aware: 1992-03-28
• Report Date: 1992-03-31
• Date Reported to FDA: 1992-03-31
• Date Reported to Mfgr: 1992-03-28
• Date Added to Maude: 1992-04-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ENTERAL ADMINISTRATION Y-ADAPTER SET
• Generic Name: UNKNOWN
• Product Code: LEY
• Date Received: 1992-04-16
• Model Number: 14-9215
• Catalog Number: UNKNOWN
• Lot Number: 9203
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 390
• Manufacturer: BIOSEARCH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-04-16