MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-09-18 for CATHETER 6-INCH 2110-0503 manufactured by Stryker Orthobiologics-malvern.
[3812877]
It was reported that the aliquot 6" catheter was used for a bone biopsy. When the surgeon attempted to remove the catheter from the cannula, he met resistance due to the strength of the bone. Additional force was required to remove the catheter; it was at this point that the handle disconnected. The catheter was manually removed and it was reported that there was no adverse consequence to the patient. On (b)(6) 2013 it was learned that there was a 20 minute procedural and as a result, this event was determined reportable. The patient recovered from the event without any harm.
Patient Sequence No: 1, Text Type: D, B5
[11084174]
Device was discarded following use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002530131-2013-00015 |
| MDR Report Key | 3355505 |
| Report Source | 07 |
| Date Received | 2013-09-18 |
| Date of Report | 2013-09-17 |
| Date of Event | 2013-08-14 |
| Date Mfgr Received | 2013-09-17 |
| Date Added to Maude | 2013-12-24 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JEREMY APELIAN |
| Manufacturer Street | 45 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104077251 |
| Manufacturer G1 | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Street | 45 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHETER 6-INCH |
| Generic Name | ALIQUOT CATHETER 6" |
| Product Code | MJG |
| Date Received | 2013-09-18 |
| Catalog Number | 2110-0503 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Address | 45 GREAT VALLEY PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-18 |