MAUDE Adverse Event Report: CONTRACT MANUFACTURING EPUMP 1000ML SAFETY SCREW SPIK; PUMP, INFUSION, ENTERAL

Model Number 775100

Device Problem Leak/Splash (1354)

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 stated that it was reported that two (02) feeding sets were observed to be leaking during set up.The reporter has informed that the samples were discarded.There are no companion samples to be returned.There are no other deficient products used during the event.There was patient involvement; however, there was no patient injury, medical intervention or adverse reactions is associated with this event.

Manufacturer Narrative

A review of the device history record (dhr) for lot number 173490126 was performed.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Unrelated failures were identified during the review.Specifically, the anom/cusum inspection detected a manufacturing issue.Some pieces had a manufacturing deficiency in the ez-cap sealing.The silicon length was registering out of specification.A 100% sort was performed and segregated the material with the irregularities.The lot was subsequently released meeting all quality standards.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be utilized for tracking and trending purposes.

• Brand Name: EPUMP 1000ML SAFETY SCREW SPIK
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CONTRACT MANUFACTURING
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 8086724
• MDR Text Key: 127862462
• Report Number: 1282497-2018-08174
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

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: Health Professional
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 173490126
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1