MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-05-17 for CUSTOM-PAK SURGICAL PROCEDURE PACK 14686 manufactured by Alcon Research, Ltd. - Houston.
[75326458]
Investigation, including root cause analysis, is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75326459]
A customer reported issue with the "pink side port knife", three nurses have injured themselves when removing the knife from the plastic holder. Upon follow up it was informed that "the type of injury experienced is a clean poke, occurring prior to contact with the patient, when opening the instrument's packaging. " there was no medical intervention indicated.
Patient Sequence No: 1, Text Type: D, B5
[80829998]
A product sample has been received at the manufacturing site and it is awaiting evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109931544]
There have been no additional complaints reported against the finish goods lot and the device history record review shows that the product was released per specifications. The customer returned four sealed straight 15 degree pink knives in pouches. The root cause of the customer? S complaint is related to the way the knives are being packaged which would be a supplier related issue. The supplier has been made aware of the issue and the sample has been sent to the supplier for their internal investigation; however, as the occurrence rate for this failure is low and this appears to be an isolated incident, no formal root cause or corrective action has been requested. Quality assurance will continue to monitor and will take action for future occurrences as deemed necessary. An internal investigation has been opened to address reports of a similar nature. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644019-2017-00423 |
| MDR Report Key | 6571785 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-17 |
| Date of Report | 2017-09-18 |
| Date Mfgr Received | 2017-09-06 |
| Device Manufacturer Date | 2016-12-16 |
| Date Added to Maude | 2017-05-17 |
| 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 | MS. NADIA BAILEY |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - HOUSTON |
| Manufacturer Street | 9965 BUFFALO SPEEDWAY |
| Manufacturer City | HOUSTON TX 77054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77054 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM-PAK SURGICAL PROCEDURE PACK |
| Generic Name | GENERAL SURGERY TRAY (KIT) |
| Product Code | OJK |
| Date Received | 2017-05-17 |
| Returned To Mfg | 2017-06-02 |
| Model Number | NA |
| Catalog Number | 14686 |
| Lot Number | 1966378H |
| Device Expiration Date | 2018-09-30 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Brand Name | CUSTOM-PAK SURGICAL PROCEDURE PACK |
| Generic Name | GENERAL SURGERY TRAY (KIT) |
| Product Code | LRO |
| Date Received | 2017-05-17 |
| Returned To Mfg | 2017-06-02 |
| Model Number | NA |
| Catalog Number | 14686 |
| Lot Number | 1966378H |
| Device Expiration Date | 2018-09-30 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - HOUSTON |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-17 |