MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-02-22 for N/A SNDSTR10G manufactured by Stryker Sustainability Solutions.
[2518203]
It was reported that while in inventory it was noticed that the diagnostic ultrasound catheter had "damaged interior wrapping/packaging. " the device was not used.
Patient Sequence No: 1, Text Type: D, B5
[9649692]
The complaint device was returned to stryker sustainability solutions (sss) for evaluation. The device was returned in its original packaging. The outer box did not appear to have any damage. The tyvek pouch was found to be ripped near the handle of the device. It appeared that the tear originated from a corner of the solid bleached sulfate (sbs) device restraint. As it appears the tear originated from a corner of the sbs restraint, it is likely that a force was applied to the restraint which caused the tyvek pouch to become punctured and tear. The outer sbs box did not appear damaged, which indicates that the damage to the inner packaging may have occurred while the device was outside of the sbs box. It is possible that the tear originated as a pinhole created at some point by the sbs restraint. If this pinhole went undetected through pre and post-sterilization inspection, it is possible that when the device was inserted into the sbs box, the pinhole caught on the corner of the restraint and tore further. However, it is also possible that this failure occurred due to mishandling subsequent to reprocessing. The device history record for the returned device shows that the device passed all inspection prior to shipment. The reported event is not occurring more frequently or with greater severity than is usual for the device.
Patient Sequence No: 1, Text Type: N, H10
[10214299]
After the initial mdr for this complaint was submitted, it was determined to add this complaint to an open capa that stryker sustainability solutions (sss) had for holes in packaging. Additional information was obtained (b)(6) 2012 regarding the above listed capa that closed on (b)(6) 2012. Based off the capa investigation, the root cause was identified as the packaging design of the restraint card utilized within the sterile barrier to restrict device motion in shipping and handling. Specifically the 90 degree corner features of the restraint have been cited as a design flaw in the restraint, providing a sharp location and the potential for breach when subjected to the dynamics of the sterilization process and handling. A new restraint assembly comprised of solid bleach sulfate was designed and tested featuring rounded edges and contours. The length of the restraint assembly was increased to protect the device connector and to reduce the pouch folding within the carton.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090040-2012-00005 |
| MDR Report Key | 2464221 |
| Report Source | 05,06,07 |
| Date Received | 2012-02-22 |
| Date of Report | 2012-01-26 |
| Date Mfgr Received | 2012-10-03 |
| Device Manufacturer Date | 2011-12-13 |
| Date Added to Maude | 2012-08-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. MOIRA BARTON-VARTY |
| Manufacturer Street | 1810 W DRAKE DR |
| Manufacturer City | TEMPE AZ 85283 |
| Manufacturer Country | US |
| Manufacturer Postal | 85283 |
| Manufacturer Phone | 4807635300 |
| Manufacturer G1 | STRYKER SUSTAINABILITY SOLUTIONS |
| Manufacturer Street | 1810 W DRAKE DRIVE |
| Manufacturer City | TEMPE AZ 85283 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85283 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | NLI |
| Product Code | OEX |
| Date Received | 2012-02-22 |
| Returned To Mfg | 2012-02-10 |
| Model Number | SNDSTR10G |
| Catalog Number | SNDSTR10G |
| Lot Number | 175887SH |
| Device Expiration Date | 2013-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS |
| Manufacturer Address | 1810 W DRAKE DRIVE TEMPE AZ 85283 US 85283 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-22 |