MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-06-02 for KIMBERLY-CLARK BALLARD MAC CATHETER * 1925 manufactured by Kimberly-clark / Ballard Med. Products.
[488136]
A kimberly-clark ballard mac catheter, catalog no. 1925 was used for surfactant delivery and was thrown away. The infant was then having respiratory issues and a chest x-ray was done without seeing anything wrong. The infant continued to have respiratory issues and when using a kimberly-clark ballard suction catheter, a catheter piece was also retrieved. The catheter used for the suction was intact. The hospital risk management department is attributing the piece to be from the mac catheter, catalog no. 1925 during the surfactant delivery procedure. They used a cutter to open the catalog no 1925 box of product. Their theory is that the catheter may have been cut at that time and the piece lodged into the infant's lungs during the surfactant delivery. Patient is reported as fine as the problem was handled in a timely manner. Kimberly-clark has no first hand knowledge of the allegations but is relaying information received from outside sources pursuant to federal regulations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719891-2006-00024 |
| MDR Report Key | 722626 |
| Report Source | 06 |
| Date Received | 2006-06-02 |
| Date of Report | 2006-06-02 |
| Date Mfgr Received | 2006-05-04 |
| Date Added to Maude | 2006-06-07 |
| 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 | 0 |
| Manufacturer Contact | RICHARD WOLFE |
| Manufacturer Street | 1400 HOLCOMB BRIDGE ROAD |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705878208 |
| Manufacturer G1 | KIMBERLY-CLARK/BALLARD MEDICAL PRODUCTS |
| Manufacturer Street | 12050 LONE PEAK PKWY |
| Manufacturer City | DRAPER UT 84020 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIMBERLY-CLARK BALLARD MAC CATHETER |
| Generic Name | TRACH CARE CATHETER |
| Product Code | KMT |
| Date Received | 2006-06-02 |
| Model Number | * |
| Catalog Number | 1925 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 711696 |
| Manufacturer | KIMBERLY-CLARK / BALLARD MED. PRODUCTS |
| Manufacturer Address | * DRAPER UT * US |
| Baseline Brand Name | TRACH CARE MULTI ACCESS CATHETER |
| Baseline Generic Name | TRACHEOBRONCHIAL SUCTION CATHETER |
| Baseline Catalog No | 1925 |
| Baseline Device Family | TRACH CARE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K872621 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-02 |