MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-23 for BONE MARROW ASPIRATION (BMA) NEEDLE RAN-11-1 manufactured by Ranfac Corp..
[1919309]
Dr. (b)(6) reported he was attempting to aspirate bone marrow from a (b)(6). After routine deep insertion of the bone marrow aspiration needle into the anterior pelvis (very hard bone was noticed) and subsequent aspiration of about 5 ml marrow, dr. (b)(6) attempted to rotate the trocar 90 degrees (per standard protocol). After penetrating the cortex of the pelvis, doctor encountered very hard bone. The needle did not want to rotate, so when he exerted add'l torque to rotate the needle, the metal cannula near the handle failed (broke) resulting in the handle being independent of the cannula which remained in bone. He then attached a power drill and chuck to the metal cannula and "powered" the cannula out of the bone. He then attempted to harvest bone marrow aspirate from the opposite pelvis with the same result and correction. He then decided to make a third, but "shallow" penetration into the pelvis that successfully resulted in 120 ml marrow being aspirated and the rest of the surgical procedures was uneventful.
Patient Sequence No: 1, Text Type: D, B5
[9092040]
Ranfac corp, the mfr, has spoken with the doctor. The device is a bone marrow aspiration needle. The instructions for use clearly state "using gentle (but firm) pressure, advance the needle by rotating in an alternating clockwise-counterclockwise motion. Entrance into the marrow cavity is generally detected by decreased resistance. " the doctor used a mallet to drive the needle into the marrow cavity. When it was time to withdraw the needle the force required was greater than that of the stainless steel. The result was the handle being broken off of the cannula. At that point, intervention became necessary. The same scenario was repeated on the other side of the pt. The needle was not used in accordance with the instructions resulting in this product problem. The "shallow" third penetration was successful because the needle was not advanced as far. Add'l lot# 20534-2.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1211566-2011-00002 |
| MDR Report Key | 2033489 |
| Report Source | 05 |
| Date Received | 2011-03-23 |
| Date of Report | 2011-03-18 |
| Date of Event | 2011-02-09 |
| Date Mfgr Received | 2011-03-14 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2011-04-28 |
| 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 | CHRISTOPHER WHELAN |
| Manufacturer Street | 30 DOHERTY AVE. PO BOX 635 |
| Manufacturer City | AVON MA 02322 |
| Manufacturer Country | US |
| Manufacturer Postal | 02322 |
| Manufacturer Phone | 5085884400 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE MARROW ASPIRATION (BMA) NEEDLE |
| Generic Name | BONE MARROW ASPIRATION (BMA) KIT |
| Product Code | LWE |
| Date Received | 2011-03-23 |
| Model Number | RAN-11-1 |
| Catalog Number | RAN-11-1 |
| Lot Number | 20533-2 |
| ID Number | NA |
| Device Expiration Date | 2015-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RANFAC CORP. |
| Manufacturer Address | 30 DOHERTY AVE. PO BOX 635 AVON MA 02322 US 02322 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-03-23 |