MAUDE Adverse Event Report: CARDINAL HEALTH ENTFLX 12FR 43IN W STYL YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721252
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the professional was removing the metal guide from the sne that had already passed on the patient when the plastic tip loosened and the metal part (which looks like a hook) entering and piercing the finger.Per additional information received on (b)(6) 2022, there was a lot of resistance to release the guidewire and the tip released from the guide wire.Curative intervention was required as a result of the puncture to the nurse.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Device evaluation comment: the customer stated that the device will not be returned for evaluation because it was discarded.
Additional 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 complaint.A sample analysis could not be performed since no photo nor actual samples were received for evaluation.Without a sample or photos evaluation, a possible root cause cannot be determined; conditions reported could not be confirmed.The manufacturing process was reviewed and determined that all process and controls were followed, including sub-assemblies, finished product assembly, packaging and inspections.Current controls includes a 100% visual inspection by production personnel according to standard work instruction.There were no abnormal conditions found that could trigger the reported condition.According to the ifu (instructions for use) for the proper procedure for insertion of the feed tube and extraction of the stylet: "using a syringe, inject approximately 10 cc of water into the tube to activate the hydromer coating." a risk assessment was performed to determine the occurrence of the reported failure mode.Based on the above analysis, the observed occurrence of harm is (0.003% and 0.004% (1, improbable) which is equal the range of the expected occurrence of harm (o) (1, improbable).The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: ENTFLX 12FR 43IN W STYL YPORT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 15396842
• Report Number: 9612030-2022-03383
• Device Sequence Number: 6179406
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/29/2022

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: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 2204101164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 09/30/2022
• 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