MAUDE Adverse Event Report: CARDINAL HEALTH DOBBHOFF 12FR;43IN W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884711253

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2022

Event Type  malfunction  

Event Description

The customer reported the tube showed resistance when they were trying to place it in the patient.They removed the tube and noticed a fold in the tube so did not place it in the patient.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One sample was received at the manufacturing site for evaluation.The sample was visually inspected and a slight fold in the tip was observed.The reported failure was confirmed; however, the failure mode reported was not confirmed as originating at the manufacturing site.A walk through was performed at the manufacturing process area.Process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging, and inspections performed to the product.In addition, quality inspections are performed before product release.This includes a visual inspection to verify correct assembly, as well a 100% visual inspection performed by production personnel during the process, in order to detect and discard any identified issues.A risk assessment was performed to determine the occurrence of the reported failure mode.The observed occurrence was in the expected range.No further action is required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: DOBBHOFF 12FR;43IN W/STYLET
• Type of Device: 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: 13479815
• MDR Text Key: 285226834
• Report Number: 9612030-2022-03159
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 2102102364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1