MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-25 for COOK CERVICAL RIPENING BALLOON W/STYLET J-CRBS-184000 manufactured by Cook Inc.
[134091401]
This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[134091402]
It was initially reported during a cervical ripening procedure, the stylet perforated the side wall of the catheter which proved painful for the patient. Subsequent investigation within the hospital has identified a training need as the member of staff was untrained and not following the instructions for use (ifu). The device was removed, a new balloon was inserted by a trained member of staff and there was no further incident. There were no adverse effects on the patient due to this occurrence. Additional information was received from the cook representative on 25jan2019. Following discussions with the hospital today, we have established this is a training issue rather than a faulty device. The member of staff concerned had never used the device before, had not attended any training and did not follow the ifu that ensures the distal tip of the stylet was firmly seated in the distal tip of the catheter. She was unaware that the stylet needed to be fixed in place. They had basic instruction from another member of staff. When the stylet perforated the side wall of the catheter it was understandably painful for the patient. The device was removed, another member of staff (midwife) inserted a new balloon and the patient went on to svd without any further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00202 |
| MDR Report Key | 8277477 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-25 |
| Date of Report | 2019-02-26 |
| Date Mfgr Received | 2019-02-20 |
| Date Added to Maude | 2019-01-25 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON W/STYLET |
| Generic Name | PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA |
| Product Code | PFJ |
| Date Received | 2019-01-25 |
| Returned To Mfg | 2019-02-14 |
| Catalog Number | J-CRBS-184000 |
| Lot Number | 9227883 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-25 |