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

Model Number 762055

Device Problem Air/Gas in Device (4062)

Patient Problem Malaise (2359)

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer who is a healthcare professional, reported that the parents of a child noticed air in the feeding line of the enteral pump set during use.The air bubble was reported to be over 10cm in length.There was no report of medical attention being required.The feeding set was replaced with another and the enteral pump use resumed.The reporter stated that the parent of the patient involved mentioned that the patient may have been unsettled, possibly related to the product issue, but this cannot be confirmed.Per the healthcare professional, there is no further information available.

• Brand Name: JOEY 500ML PUMP SET
• Type of Device: 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 ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11878310
• MDR Text Key: 252968302
• Report Number: 1282497-2021-10223
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521072299
• UDI-Public: 10884521072299
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 762055
• Device Catalogue Number: 762055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1