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

Model Number 8884711253

Device Problems Use of Device Problem (1670); Separation Failure (2547)

Patient Problem Laceration(s) (1946)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

Customer reports: the pull tab attached to the guide wire failed and came off.This led to a staff members hand being cut.Per additional information received on (b)(6) 2022, the incident occurred during use on a patient after placement.The staff reported mild resistance but no more than you would usually feel when pulling the guidewire.A set of kelly clamps was used to complete the removal of the guidewire.The guidewire broke through the glove and cut into the thumb causing bleeding.The patient was unaffected by the incident.The staff member was sent to the er for blood work and first aid.There will be a 6 month blood work follow up.

Manufacturer Narrative

An investigation is currently underway.The device has been discarded.Upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.A sample analysis was not possible since there was no sample submitted for review.A photograph from the catalog was submitted however it was not an actual sample photo therefore the reported condition could not be confirmed.Without the sample to evaluation the root cause could not be identified.No action plan is required since the reported condition probability of harm is =0.001%.The observed occurrence rate is 0.00276% (improbable (1)) which is below the range of the expected occurrence.

• 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: 13953698
• MDR Text Key: 297584461
• Report Number: 9612030-2022-03197
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• 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: 2200305464
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1