MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES; SET,PUMP,1000ML BAG,ENFIT,MEDLINE

Model Number	ENFIT70552
Health Effect - Clinical Code	Feeding Problem (1850)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the feeding bag cracked and pieces got stuck in the gtt, which stopped medication and feedings.According to the customer, this was a female metabolic patient and the pieces had to be removed with kelly clamps.Reportedly, the incident was considered major harm to the patient, as they had to stop all medication and feedings.The customer stated a gi specialist had to come to evaluate tube replacement before the feedings and medications could be reinstated with the patient.No additional information is available.Due to the reported event and medical intervention to stop all medication and feedings, this is a mdr reportable event.The root cause could not be identified at this time.If additional information becomes available, this report will be re-opened re-evaluated.
Event or Problem Description
It was reported the feeding bag crack and pieces got stuck in the gtt, which stopped medication and feedings.

• Brand Name: MEDLINE INDUSTRIES
• Common Device Name: SET,PUMP,1000ML BAG,ENFIT,MEDLINE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10205647
• Report Number: 1417592-2020-00074
• Device Sequence Number: 2107408
• Product Code: KNT
• UDI-Device Identifier: 10884389190333
• UDI-Public: 10884389190333
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ENFIT70552
• Device Catalogue Number: ENFIT70552
• Device Lot Number: 0031808A037
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention