MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for QUICKLINK DELIVERY SYSTEM LOADER 70310QCA1 manufactured by Bard Brachytherapy, Inc. -1424526.
[46781235]
The device was not returned for evaluation however the complaint was confirmed as a user related issue based on the event description. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "extra care should be taken to avoid exposing the quicklink cartridges containing bioabsorbable sourcelink component to excessive heat or moisture. " "after sterilization, allow the quicklink delivery system loader components to cool to room temperature prior to use. " (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Sample not available.
Patient Sequence No: 1, Text Type: N, H10
[46781236]
It was reported that the links were left in the quick link loader by mistake after a training session. The loader was then delivered to theater and autoclaved. The links melted into the groove of the machine and it was impossible to remove them. As the loader was sterilized, it was only opened in the theater by the scrub sister once they were ready to work. At the time, the patient was already under anesthetics and the needles were in place. We had to wait for the replacement machine to get delivered from the bard offices in (b)(4), extending the theater time by around 1 hour, a significant delay.
Patient Sequence No: 1, Text Type: D, B5
[57731533]
The device was not returned for evaluation however the complaint was confirmed as a user related issue based on the event description. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "extra care should be taken to avoid exposing the quicklink cartridges containing bioabsorbable sourcelink component to excessive heat or moisture. " "after sterilization, allow the quicklink delivery system loader components to cool to room temperature prior to use. " (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Sample not available.
Patient Sequence No: 1, Text Type: N, H10
[57731534]
It was reported that the links were mistakenly left in the quick link loader after a training session. The loader was then delivered to the theater and autoclaved. The links melted into the groove of the machine and it was impossible to remove them. As the loader was sterilized, it was only opened in the theater by the scrub sister once they were ready to begin the procedure. At that time, the patient was already under anesthetics and the needles were in place. As a result, the device had to be immediately replaced which was delivered from the bard offices in (b)(6), extending the theater time approximately 1 hour, which was a significant delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2016-00704 |
| MDR Report Key | 5685042 |
| Date Received | 2016-05-27 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-05-05 |
| Date Mfgr Received | 2016-09-29 |
| Device Manufacturer Date | 2013-09-27 |
| Date Added to Maude | 2016-05-27 |
| 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 | JANNA PARKS |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | BARD BRACHYTHERAPY, INC. -1424526 |
| Manufacturer Street | 295 EAST LIES ROAD |
| Manufacturer City | CAROL STREAM IL 60188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICKLINK DELIVERY SYSTEM LOADER |
| Generic Name | QUICK LINK |
| Product Code | IWJ |
| Date Received | 2016-05-27 |
| Catalog Number | 70310QCA1 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD BRACHYTHERAPY, INC. -1424526 |
| Manufacturer Address | 295 EAST LIES ROAD CAROL STREAM IL 60188 US 60188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-05-27 |