MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PNEUMOTHORAX KIT; PROSTHESIS, ELBOW, CONSTRAINE

Catalog Number AK-01500

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information received in which the customer reports that the issue they experienced was due to user error.The customer wanted to inform teleflex of this issue.Clinical education training to be provided by sales rep.On (b)(6) 2019 the customer reports that the patient had a follow-up visit at the trauma clinic and has no deficits.

Event Description

The customer reports: the clinician did not remove the peelable contamination guard that was over the catheter.They inserted this guard into the cavity of the patient.When the patient was at home, they felt respiratory issues and had to return to get the contamination guard surgically removed.The reported defect was detected after use.There is no patient injury or consequence.The patient condition is reported as "fine".There was a reported patient complication.Therapy was reported to be delayed/interrupted.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with this kit instructs the user "insert catheter into pleural space with tip directed toward apex of lung.Guard can be used to support catheter during insertion.To remove guard , continue to pull back.Guard will "peel off" catheter." the customer confirmed that the contamination guard was not removed as it should have been due to use error indicating that they are aware of proper use of the device and the use error was unintentional.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: the clinician did not remove the peelable contamination guard that was over the catheter.They inserted this guard into the cavity of the patient.When the patient was at home, they felt respiratory issues and had to return to get the contamination guard surgically removed.The reported defect was detected after use.There is no patient injury or consequence.The patient condition is reported as "fine".There was a reported patient complication.Therapy was reported to be delayed/interrupted.

• Brand Name: ARROW PNEUMOTHORAX KIT
• Type of Device: PROSTHESIS, ELBOW, CONSTRAINE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9260568
• MDR Text Key: 164469577
• Report Number: 9680794-2019-00422
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K904021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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 Catalogue Number: AK-01500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention