MAUDE Adverse Event Report: QIAGEN DIGENE HC2 DNA COLLECTION DEVICE

Catalog Number 5122-1220

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Distress (2329); Discomfort (2330); Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016 incident occurred and was reported to qiagen technical service.On (b)(6) 2016 device was removed from patient without injury.On 07mar2016 device was received at qiagen for evaluation.Unused devices from the same kit box were also sent for evaluation.On 15mar2016 defective device was inspected side by side with an unused device.The affected device showed no evidence of going through the heat step in the assembly process.This heat step helps secure the brush head to the shaft.On 16mar2016 defective device returned to the supplier for further investigation.

Event Description

On (b)(6) 2016 qiagen received a report, (b)(4), from (b)(6) where the brush head became detached from the shaft and remained inside the patient's cervix.Due to the patient's narrow cervix, the doctor could not easily remove the brush with forceps.Two days later the brush was removed from the patient under anesthesia without causing injury.

Manufacturer Narrative

Final evaluation of the returned device concluded that a manufacturing step was missed.This defect is not likely to cause a serious adverse event.

Event Description

On 24feb2016 qiagen received a report, (b)(4), from (b)(6) where the brush head became detached from the shaft and remained inside the patient's cervix.Due to the patient's narrow cervix, the doctor could not easily remove the brush with forceps.Two days later the brush was removed from the patient under anesthesia without causing injury.

• Brand Name: DIGENE HC2 DNA COLLECTION DEVICE
• Type of Device: DIGENE HC2 DNA COLLECTION DEVICE
• Manufacturer (Section D): QIAGEN; 19300 germantown road; germantown MD 20874
• Manufacturer (Section G): QIAGEN; 19300 germantown road; germantown MD 20874
• Manufacturer Contact: donna sowers ; 19300 germantown road; germantown, MD 20874 ; 2406867876
• MDR Report Key: 5525063
• MDR Text Key: 41534673
• Report Number: 1122376-2016-00010
• Device Sequence Number: 1
• Product Code: HHT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/06/2017
• Device Catalogue Number: 5122-1220
• Device Lot Number: 170407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• 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 Age: 59 YR