MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INTL PONSKY PULL PEG 20F; FEEDING TUBE

Model Number 010060

Device Problem Fluid/Blood Leak (1250)

Patient Problems Abscess (1690); Inflammation (1932); Pain (1994)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(b)(4).(expiration date: 12/2023).

Event Description

It was reported that approximately one week post gastrostomy feeding tube placement, the device was allegedly leaking.It was further reported that the patient was admitted to the hospital due to alleged pain, sepsis, and wall abscess around the stoma.Reportedly, treatment for the infection was provided and the device was replaced.The patient status is unknown.

• Brand Name: INTL PONSKY PULL PEG 20F
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9112931
• MDR Text Key: 159893888
• Report Number: 3006260740-2019-02815
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00801741081200
• UDI-Public: (01)00801741081200
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K915841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 010060
• Device Catalogue Number: 010060
• Device Lot Number: HUCX2904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 67 YR