MAUDE Adverse Event Report: CARDINAL HEALTH CONT. FEEDING SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884741821
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
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.
Event or Problem Description
The customer reported that the right angled port was coming away from the tubing within 2 weeks of use.It was a possible glue issue.Per additional information received, there was no medical intervention required.
Additional Manufacturer Narrative
Additional information h2, h3, h6.Investigation conclusion the customer reported that the right angled port is coming away from the tubing (possible glue issue) within 2 weeks of use.The reported product, 8884741821, cont.Feeding set, with lot number unk was investigated.Failure mode trending was reviewed, and no related adverse trends were identified.A total of seven (7) products, without original packaging, were returned for evaluation.Visual inspection of the returned products confirmed the reported product failure.Five (5) of the seven (7) returned products showed evidence of the reported tubing detachment.A root cause investigation was performed by way of a gemba walkthrough of the manufacturing process.In general, all processes and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.No manufacturing process abnormalities or defects were identified.A potential root cause of the confirmed product failure was identified as incorrect adhesive placement during assembly.The following actions have been taken: a quality alert was issued to applicable personnel to ensure proper assembly and an awareness notification was issued to the applicable production personnel.This complaint will be used for monitoring and trending purposes.

• Brand Name: CONT. FEEDING SET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12803734
• Report Number: 9612030-2021-03086
• Device Sequence Number: 14627427
• Product Code: KNT
• UDI-Device Identifier: 20884521023960
• UDI-Public: 20884521023960
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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
• Device Model Number: 8884741821
• Device Catalogue Number: 8884741821
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown