MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 12F GUIDEWIRE J-TUBE; FEEDING DEVICE

Model Number	000734
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical images or medical records have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the device is pending to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that approximately one week post guide wire implant, the tubing at the distal junction allegedly started to leak which continued for approximately three weeks causing inaccurate enteral feedings.It was further reported that the guide wire was changed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one jejunal/gastric decompression catheter 12f guidewire was returned for evaluation.Functional and gross visual evaluations were performed.The investigation is confirmed for partial break/leak in the catheter as a leak was observed around the base of junction when the suction port was infused.Microscopic evaluation showed a crack on the catheter surface near the junction of the catheter and the adapter.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that approximately one week post guide wire implant, the tubing at the distal junction allegedly started to leak which continued for approximately three weeks causing inaccurate enteral feedings.It was further reported that the guide wire was changed.There was no reported patient injury.

• Brand Name: 12F GUIDEWIRE J-TUBE
• Common Device Name: FEEDING DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7871677
• Report Number: 3006260740-2018-02430
• Device Sequence Number: 19454968
• Product Code: KNT
• UDI-Device Identifier: 00801741051685
• UDI-Public: (01)00801741051685
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K946249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: Health Professional
• Device Model Number: 000734
• Device Catalogue Number: 000734
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1