MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-24 for DIGENE HC2 DNA COLLECTION DEVICE 5122-1220 manufactured by Qiagen.
[41534673]
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.
Patient Sequence No: 1, Text Type: N, H10
[41534674]
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.
Patient Sequence No: 1, Text Type: D, B5
[59479921]
Final evaluation of the returned device concluded that a manufacturing step was missed. This defect is not likely to cause a serious adverse event.
Patient Sequence No: 1, Text Type: N, H10
[59479922]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2016-00010 |
| MDR Report Key | 5525063 |
| Date Received | 2016-03-24 |
| Date of Report | 2016-03-24 |
| Date of Event | 2016-02-24 |
| Date Mfgr Received | 2016-02-24 |
| Device Manufacturer Date | 2014-10-06 |
| Date Added to Maude | 2016-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS DONNA SOWERS |
| Manufacturer Street | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal | 20874 |
| Manufacturer Phone | 2406867876 |
| Manufacturer G1 | QIAGEN |
| Manufacturer Street | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIGENE HC2 DNA COLLECTION DEVICE |
| Generic Name | DIGENE HC2 DNA COLLECTION DEVICE |
| Product Code | HHT |
| Date Received | 2016-03-24 |
| Returned To Mfg | 2016-03-07 |
| Catalog Number | 5122-1220 |
| Lot Number | 170407 |
| Device Expiration Date | 2017-10-06 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QIAGEN |
| Manufacturer Address | 19300 GERMANTOWN ROAD GERMANTOWN MD 20874 US 20874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-24 |