MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-28 for JAMSHIDI BONE MARROW NEEDLES UNKNOWN manufactured by Carefusion, Inc.
[70998451]
(b)(4) initial emdr submission. A follow up emdr will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[70998452]
Customer stated via email: the bone marrow aspirate needle broke and stuck in patient's posterior iliac crest. Surgery consulted. No patient harm, but the patient did have to go to the or to get it removed. The date was (b)(6) 2017. Additional information received 6mar2017: can you please provide patient information? I. E. Initials, age, gender, weight we cannot provide this information. Can you please find out the product code/lot number for the defective product? We have the product to return, but do not have the product code. Approximately how long was the retained piece of needle? Unable to confirm the length of the piece of retained needle. (b)(6) md, the physician performing the procedure stated in her procedure note, the needle broke with 1-1. 5 inches remaining in the patient. Was the patient's stay in the hospital extended due to the surgical procedure to remove the broken needle? The patient had to have the surgical procedure, but he was discharged to home after the procedure, same day, is my understanding. The impact to the patient included the need to be intubated, have extended anesthesia and an or procedure to remove the retained portion of the needle. What is the status of the patient now in relation to the reported issue? As for status of the patient, here is what was noted in the post op note: the patient lives in florida. I will attempt to do a telemedicine-type encounter in about a week's time. I am happy to see him back when he returns for a repeat bone marrow in 6-8 weeks' time. Signed by (b)(6) md.
Patient Sequence No: 1, Text Type: D, B5
[76532943]
(b)(4) follow up emdr for device evaluation. Three jamshidi biopsy needles were returned for analysis. One needle was broken off at approximately 1. 5? From the distal end. The two remaining needles were observed to be bent. Therefore, the reported defect was confirmed. Visual inspection of the returned product confirmed that one needle was broken, and two were bent. The device history record for these components was unavailable as no lot number was reported with the complaint. The returned samples showed signs of excessive force applied to the needles causing the cannula of the needle to bend. However, the investigation was not able to identify a probable root cause due to a lack of information regarding the specific forces applied to the respective needle during use. A root cause could not be established, therefore corrective actions are not indicated. Record of the complaint will be made in the complaint tracking system. Likewise, the customer will be made aware of the specific cautionary statement provided with the instructions for use regarding the application of excessive force during the placement and redirection of the bone marrow biopsy needle. Bd will continue to track and trend this failure mode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2017-00278 |
| MDR Report Key | 6438754 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-28 |
| Date of Report | 2017-05-30 |
| Date of Event | 2017-03-02 |
| Date Mfgr Received | 2017-03-03 |
| Date Added to Maude | 2017-03-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAMSHIDI BONE MARROW NEEDLES |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2017-03-28 |
| Returned To Mfg | 2017-03-13 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-28 |