MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-11 for ACMF CARDIO PACK BLUE 2 77762 991077762 manufactured by Kimberly-clark Health Care.
[4605232]
Kimberly-clark received a report from (b)(6) stating,? The plastic bag in which the set is packaged is not welded properly. The customer could not use the 4 sets, since they are sterile. The seal is only a part open, the weld is risen again. In the 13 cases (13 cases x 2 packs) inspected we found 3 packs with a broken seal. It seems that the packs burst on the edge due to the pressure. For some of the other packs the seal which is at 1 cm wide was starting to open from the interior, leaving just a few millimeters of unbroken seal at the exterior side. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11915757]
We are unable to review the device history record as no lot number was provided for the device involved in this reported event. The device was not returned to kimberly-clark for evaluation, therefore we are unable to determine a root cause for the reported event. Information from this incident will be included in our product complaint and mdr trend reporting systems. Ongoing analysis of trend information is used to identify the need for additional investigations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033422-2014-00018 |
| MDR Report Key | 3929628 |
| Report Source | 06 |
| Date Received | 2014-07-11 |
| Date of Report | 2014-06-11 |
| Date Mfgr Received | 2014-06-11 |
| Date Added to Maude | 2014-07-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RA/QA AE COORDINATOR |
| Manufacturer Street | 1400 HOLCOMB BRIDGE ROAD |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer G1 | AVENT S DE RL DE CV/NOGALES 3 |
| Manufacturer Street | AV. HIDALGO #6 ESQUINA BLVD LUIS DONALDO COLOSIO, COL. EDUCATIVA |
| Manufacturer City | NOGALES, SONORA 84093 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACMF CARDIO PACK BLUE 2 |
| Generic Name | SURGICAL PACKS |
| Product Code | FYC |
| Date Received | 2014-07-11 |
| Model Number | 77762 |
| Catalog Number | 991077762 |
| Lot Number | AC322103B |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK HEALTH CARE |
| Manufacturer Address | 1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-11 |