MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-02-20 for "WARMERS, INFANT HEEL W/TABS" MH00002T manufactured by Covidien.
[136713270]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[136713271]
The customer reports heel warmer exploded on the nurse. The nurse rinsed the area and did not feel a need to go to emergency department.
Patient Sequence No: 1, Text Type: D, B5
[139888104]
(b)(4). No lot number was provided. A review of the device history record (dhr) was unable to be performed. However, all dhrs are reviewed for accuracy prior to product release. In-process procedures are also in place to prevent nonconforming product in the manufacturing process. This ensures components and finished products meet all quality inspection standards. These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification. During production all product is held and 100 % inspected after manufacture to ensure that no pre-activation or leaking occurs. Any product exhibiting signs of obvious damage or pre-activation are scrapped. No product/sample was provided for evaluation due to being discarded by the reporting facility. No additional information, pictures or videos were received. Without a product sample, further investigation could not be conducted. Previous investigations for burst issues indicated that once the product is received in the distribution center, the product is removed from their cases and cartons, placed in bags and distributed to the required medical facility. The product being exposed to logistic movements may cause activation or wear on the seals if they are not handled as fragile. Since they may be subject to removal from their original protective packaging for transit and/ or distribution, no manufacturing related root causes can be determined. The product may have been hit against a surface putting too much force on the pouch during shipment. Because this heel warmer was potentially mishandled during logistics and activated against the instructions on the provided packaging and artwork, this complaint cannot be confirmed and is not considered manufacturing related. Additional end use storage information was requested to provide clarification for this event. No information was provided. Additional causes for the heel warmers to burst in the field may include the storage and handling of the product once it leaves the distribution center. The individual pouches do not have identifying lot numbers, so lot to lot identification for issues in unable to be determined for this reported condition. The heal warmers should be stored in their original packaging until immediately prior to use. It is important to note that the heel warmer product cases labels and pouches are labeled as fragile, so care is needed during the shipment, storage and use of product. Packaging instructions also provide vital information for intended use. It is recommended that the end user identify corrective actions with the appropriate distribution centers to ensure their products are transported and stored in the protective cases/cartons and stored as such until ready for use. These actions will prevent heavy or sharp objects from inadvertently causing damage to the seals of the product before arrival or during storage at the medical facility; as well as maintain the integrity of the seals. The reported customer complaint is not confirmed. A root cause could not be determined. A probable root cause was determined to be end use handling/misuse and/or storage of the product. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219103-2019-00225 |
| MDR Report Key | 8355242 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-20 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-02-11 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-02-20 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524970 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2 LUDLOW PARKWAY |
| Manufacturer City | CHICOPEE MA 01022 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | "WARMERS, INFANT HEEL W/TABS" |
| Generic Name | INFANT HEEL WARMER (CHEMICAL HEAT PACK) |
| Product Code | MPO |
| Date Received | 2019-02-20 |
| Model Number | MH00002T |
| Catalog Number | MH00002T |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-20 |