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

Model Number	77000FD
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The patient's husband reported that there was air in the tubing between the bottle and the pump during feeding.The customer changed the set and even though the debit was set to 90ml/hr and volume at 850ml, after 6hr only 225ml was administered (based on the amount left in the bottle).The patient is fed overnight (9pm-6:25am) for a total of 9h25min at 90ml/hr and a volume of 850ml.The patient is fed twocal hn b j-tube.The patient was not over/under fed.The feeding took longer the second time the set was changed but the customer does not remember how much longer.The sets are changed on a daily basis.There was no patient harm.

• 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: 11016483
• Report Number: 1282497-2020-09792
• Device Sequence Number: 4241419
• Product Code: LZH
• UDI-Device Identifier: 10884521190818
• UDI-Public: 10884521190818
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: 182430149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/16/2020
• Patient Sequence Number: 1