MAUDE Adverse Event Report: COVIDIEN; PUMP, INFUSION, ENTERAL

Model Number UNKNOWN ENTERAL ACCESS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 07/17/2017

Event Type  Injury  

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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that the patient had a peg site infection, for which she was treated with oral antibiotics.The type of antibiotics administered is unknown and there is no additional information available.The peg tube is still in use and will not be returned.

• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125; cuidad industrial; tijuana,mx 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125; cuidad industrial; tijuana,mx 22500 ; MX 22500
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6756963
• MDR Text Key: 81497380
• Report Number: 9612030-2017-05132
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ENTERAL ACCESS
• Device Catalogue Number: UNKNOWN ENTERAL ACCESS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1