MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-09-07 for 6715 KERLIX RL STERILE 1'S manufactured by Covidien.
[119635597]
The customer states he received a voicemail from a patient? S son that said his mother recently passed away from an infection and that they were unsure of where the infection came from. His mother had received a few letters from the distributor regarding the voluntary recall of the kerlix because she had received two products with the lot numbers that were voluntarily recalled. After receiving the letters they believe her infection was caused by the product.
Patient Sequence No: 1, Text Type: D, B5
[134628624]
No lot number was provided. A review of the device history report (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. No product/sample was provided for evaluation. No additional information, pictures or videos were received. Therefore, a comprehensive investigation was unable to be conducted. The reported customer complaint could not be confirmed. However, due to the description of the complaint, it is noted that a capa was opened to address issues with open seals and pinched seals. It was found that machine was producing primary packages with open seals. These packages are a flexible sealed pouch that contains the product. However, since no lot number was provided, it is unclear whether this complaint is directly related to the capa. Additional contact was made with the reporter of this event to obtain samples/specific lot numbers. It was relayed that samples/lot numbers may be available, but will advise if able to locate/forward. As of this report, no further information has been received. The root cause of the capa investigation was a broken bolt on the assist sealing die lift cylinder. Due to the damaged hardware resulting from the broken bolt, the sealing die did not perform properly. The results were open seals and pinched seals on packages. While the plastic is forming the trays it will be softened by two heating stations then formed. The plastic is first heated with contact heater on both sides. Air pressure is then applied during the heat cycle to form the tray. Without sufficient pre-heat form temperature, although improbable, could affect poor tray quality, resulting in thin areas, holes, or distortion. An impact assessment was completed and issued to document this investigation and actions relative to hazard and risk identification. Corrective action was then put into place to correct the broken bolt and improve the process to eliminate open and pinched seals. The broken bolt on the assist cylinder sealing die lifting system was replaced. Installation of new alignment pins on bottom seal die net to prevent movement. Extend the web support rails at the entry and exit points of the sealing die. Preventive actions consisted of an evaluation of the equipment by multivac service technician. Production resumed but the product is being 100% inspected and any impacted lots are contained. The reported customer complaint was unable to be confirmed. A root cause could not be determined. Based on complaint description, a probable root cause was determined to be a broken bolt on the assist sealing die lift cylinder. This complaint will be utilized for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018120-2018-00302 |
| MDR Report Key | 7857366 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-09-07 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-09-06 |
| Date Added to Maude | 2018-09-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1430 MARVIN GRIFFIN ROAD, PO B |
| Manufacturer City | AUGUSTA GA 30906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6715 KERLIX RL STERILE 1'S |
| Generic Name | GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2018-09-07 |
| Model Number | 6715 |
| Catalog Number | 6715 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN ROAD, PO B AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-09-07 |