MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-06 for PLEURAFLOW SYSTEM WITH FLOWGLIDE PFFG-32 manufactured by Clearflow, Inc..
[76832622]
The device was evaluated and a definite root cause could not be determined. Reported detachment of the chest barb was confirmed. Failure investigation identified the possibility that the guide tube was not fully inserted in the chest barb during assembly. A review of complaint history, drawings, trends, instructions for use, manufacturing instructions, quality control, lot history and visual inspection and dimensional verification of the returned device was conducted during the investigation. Product met all dimensional requirements. No definite cause of failure could be determined. A supplier corrective action was issued to the contract manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[76832623]
Device functioned as intended during the first one hour in the operating room. Upon initial use in the icu, the chest barb, a component of the clearance apparatus, separated from the guide tube component of the clearance apparatus. The chest tube was left in the patient's chest and clamped immediately. A new sterile package was opened in the icu and a new clearance apparatus was connected to the chest tube. The device was used with no further problems until its removal at end of normal use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008782989-2017-00005 |
| MDR Report Key | 6616895 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-06 |
| Date of Report | 2017-05-31 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-05-12 |
| Device Manufacturer Date | 2017-04-14 |
| Date Added to Maude | 2017-06-06 |
| 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 | DR. DOV GAL |
| Manufacturer Street | 1630 S. SUNKIST STREET SUITE E |
| Manufacturer City | ANAHEIM CA 92806 |
| Manufacturer Country | US |
| Manufacturer Postal | 92806 |
| Manufacturer Phone | 7149165014 |
| Manufacturer G1 | XERIDIEM MEDICAL DEVICES |
| Manufacturer Street | 4700 S. OVERLAND DR. |
| Manufacturer City | TUCSON AZ 85714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEURAFLOW SYSTEM WITH FLOWGLIDE |
| Generic Name | PLEURAFLOW SYSTEM WITH FLOWGLIDE |
| Product Code | OTK |
| Date Received | 2017-06-06 |
| Returned To Mfg | 2017-05-12 |
| Model Number | PFFG-32 |
| Catalog Number | PFFG-32 |
| Lot Number | 961602 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLEARFLOW, INC. |
| Manufacturer Address | 1630 S. SUNKIST STREET SUITE E ANAHEIM CA 92806 US 92806 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-06 |