MAUDE Adverse Event Report: COVIDIEN CONNECT SFTY SCREW SPIKE NS; PUMP, INFUSION, ENTERAL

Model Number	77000FD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported the feed leaks where the spike of the feeding set connects to the feed bottle.There was no patient harm.
Additional Manufacturer Narrative
A device history record review reveled no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.One used sample was returned for evaluation.A visual and functional inspection was carried out according to product specifications however the reported condition was not present in the returned sample.The reported condition could not be confirmed.A root cause could not be determined, nor could it be attributed to the manufacturing process of this device.This complaint will be closed with no further action.This complaint will be used for tracking and trending purposes.

• Brand Name: CONNECT SFTY SCREW SPIKE NS
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11978890
• Report Number: 1282497-2021-10245
• Device Sequence Number: 1085755
• Product Code: LZH
• UDI-Device Identifier: 10884521190818
• UDI-Public: 10884521190818
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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
• Operator of Device: No Information
• Device Model Number: 77000FD
• Device Catalogue Number: 77000FD
• Device Lot Number: 190590034
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1