MAUDE Adverse Event Report: COVIDIEN JOEY 500ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number	762055
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that registered nurse (rn) had administered medications through a nasojejunal tube (flushed appropriately) and restarted feeds.The pump began ringing ¿occluded downstream¿.The feed was paused, and nj tube flushed with no resistance.On inspection of feeding bag/pump, the cassette was noted to be leaking.The bag was replaced with a new feeding set and no further issues were noted.Additional information was received from the customer and stated that the line was not occluded.
Additional Manufacturer Narrative
Additional information h2, h3, h6.Investigation conclusion the customer reported that registered nurse (rn) had administered medications through a nasojejunal tube (flushed appropriately) and restarted feeds.The pup began ringing ¿occluded downstream¿.The feed was paused, and nj tube flushed with no resistance.On inspection of feeding bag/pump, the cassette was noted to be leaking.The bag was replaced with a new feeding set and no further issues were noted.The report refers to product code 762055, joey 500ml pump set, with unknown lot number was investigation.A device history record (dhr) review was not performed as the lot number was not provided.Failure mode trending was reviewed, and no related adverse trends were identified.One (1) used product was returned for evaluation.Visual inspection and functional evaluation performed found no product fault.The product met specification and operated as intended; therefore, the reported product failure was not confirmed.Additional action will not be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: JOEY 500ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12420937
• Report Number: 1282497-2021-10586
• Device Sequence Number: 3332802
• Product Code: LZH
• UDI-Device Identifier: 10884521072299
• UDI-Public: 10884521072299
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 762055
• Device Catalogue Number: 762055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown