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

Catalog Number	ENFIT70552
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was initially reported that on (b)(6) 2019 (time not reported), the feeding set was noted leaking and on (b)(6) 2019 at 01:30 am, the patient's blood sugar level was 34 mg/dl (low blood sugar).Per report, patient received bolus of dextrose 25% and dextrose 10% in water was given as maintenance fluid.The patient's blood sugar level reportedly improved to 172 mg/dl after the treatment was given.It was added that broken pieces of the feeding set connector was noticed in the nasojejunal tube.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural/event details.Due to the reported event and medical intervention required for hypoglycemia, this medwatch is being filed.The sample was returned for evaluation and the complaint of cracked feeding set connector was confirmed.A definitive root cause could not be identified at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the feeding set was leaking and patient required treatment for hypoglycemia.

• Common Device Name: SET,PUMP,1000ML BAG,ENFIT,MEDLINE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8607683
• Report Number: 1417592-2019-00067
• Device Sequence Number: 2180561
• Product Code: KNT
• UDI-Device Identifier: 10884389190333
• UDI-Public: 10884389190333
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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 Catalogue Number: ENFIT70552
• Device Lot Number: 96918090001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/14/2019
• 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