MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. ARTERIAL BLOOD SAMPLING PRO-VENT PLUS; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Device Problem Fracture (1260)

Patient Problems Nerve Damage (1979); Pain (1994); Tingling (2171); Numbness (2415); Foreign Body In Patient (2687)

Event Date 03/05/2012

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

The following was reported by notification of lawsuit against healthcare facility: patient was taken to the hospital as a result of a seizure on (b)(6) 2012.Abg's and labs were ordered.Respiratory technician (rt) attempted the abg draw at the distal volar forearm.Rt was not successful with initial attempt.Second attempt at the same site was also unsuccessful.Following attempts, patient reported immediate and unusual pain and refused a third attempt.Over the next 17 days, the patient experienced wrist pain, tingling sensations, and a decreased ability to use her right index finger and thumb.Patient returned to hospital on (b)(6) 2012 and wrist x-rays were ordered.X-ray revealed a 7mm fragmented needle located in the volar soft tissue of the patient's right forearm.Surgery was performed to remove the fragment.Patient continued to experience numbness and tingling of the finger and thumb, along with wrist weakness and pain.On (b)(6) 2012, an electromyogram and nerve conduction study revealed the patient had moderate prolongation of distal motor latency of her right median nerve.

• Brand Name: ARTERIAL BLOOD SAMPLING PRO-VENT PLUS
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 10 bowman drive; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5350895
• MDR Text Key: 35255137
• Report Number: 2183502-2016-00035
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Respiratory Therapist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention