MAUDE Adverse Event Report: COVIDIEN 777501 JOEY ENPLUS SPIKE SET X30; PUMP, INFUSION, ENTERAL

Model Number 777501

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the tubing split into 2 parts during the feeding process resulting in a leak of the feeding product.The was no harm to patient.

Manufacturer Narrative

510k is listed as unknown because this product is not sold in the united states.The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of the reported lot.The complaint report indicates that there is no sample available.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation.Unfortunately, without a sample we are unable to confirm the reported condition.If a sample should be returned the complaint will be reopened and the investigation updated to reflect our finding.Root cause and corrective action could not be determined without a sample to evaluate.This compliant cannot be confirmed without the sample returned.The associated data will be fed into the risk management quarterly report.It should be noted that follow up received from the initial reporter stated the tubing was tested in the facility and they were found not to be defective.The initial reporter also contacted the patient who also stated the incident did not have a relation with the tubing.

• Brand Name: 777501 JOEY ENPLUS SPIKE SET X30
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 9099919
• MDR Text Key: 159786206
• Report Number: 9611018-2019-00337
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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 Operator: No Information
• Device Model Number: 777501
• Device Catalogue Number: 777501
• Device Lot Number: 17K085FHX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 10/18/2019
• Patient Sequence Number: 1