MAUDE Adverse Event Report: BARD PEG NEEDLE

Lot Number HUXJ0984

Device Problem Bent (1059)

Patient Problems Transient Ischemic Attack (2109); Weakness (2145)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

This (b)(6) female with history of seizures, atrial fibrillation on coumadin and cad (coronary artery disease), presented to the emergency department on (b)(6) 2014 with left sided weakness associated with altered mental status.The patient was admitted with an acute ischemic stroke in the posterior infarct and right cerebellar hemisphere.She was maintained on npo (no food by mouth) status and received nutrition via ng (nasogastric) tube.Peg (percutaneous endoscopic gastrotomy) placement was completed on (b)(6) 2014 at which time the peg needle bent to a 90 degree angle.The needle was removed/retrieved and the procedure ensued utilizing another kit/needle; no further complications were noted.The patient was transferred back to a nursing home on (b)(6) 2014 with instructions to follow-up with the neurology team.

• Brand Name: PEG NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): BARD
• MDR Report Key: 3619229
• MDR Text Key: 4136503
• Report Number: MW5034234
• Device Sequence Number: 1
• Product Code: KNT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: HUXJ0984
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Weight: 56