MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-27 for JAMSHIDI NEEDLE BONE MARROW 13GX3.5 ASP DJ3513X manufactured by Carefusion, Inc.
[44467093]
(b)(4)-upon completion of investigation a follow up emdr will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44467094]
Upon cleaning instrument tray following difficult bone marrow aspiration, the rn noted that one of the jamshidi needles ( identified above) was notably shorter than usual. The end of the outer section was approximately 3 cm shorter than a comparison needle of the same product code and lot number. The end was also bent. No needle piece could be located. Patient is being followed in case piece broke off during procedure. Noticed during/after procedure. On (b)(6) 2016: has the piece of needle since been located? No. Prior to initiating procedure, was the jamshidi needle checked for anomalies? Prior to the procedure there was no anomalies on the jamshidi needle as per the attending physician. To date, has patient had imaging to rule out retained needle? No there were no concerns regarding the procedure, no further investigations were performed. (see also response to next question). Has patient required any additional intervention or medical attention as a result of possible retained needle? "the patient and her daughter came to my office on (b)(6) 2016 for follow up, i told them that the procedure was technically difficult and the tip of the jamshidi needle was missing, the patient denied any pain on the site of the biopsy.
Patient Sequence No: 1, Text Type: D, B5
[47949514]
(b)(4). One (1) sample from lot #0000694947 was received for evaluation. During visual analysis failure mode could be confirmed since the needle was broken. A review of the internal manufacturing device record and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found. It was confirmed that procedural and functional requirements needed for its release were met. Lot # 0000694947 was manufactured on 08/28/2014. Conclusion(s): supplier- defective component: most probable cause of failure mode reported could be related with material provided from our supplier. We have issued a supplier corrective action request. To date we are waiting on response.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2016-00078 |
| MDR Report Key | 5611193 |
| Date Received | 2016-04-27 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-03-31 |
| Date Mfgr Received | 2016-04-06 |
| Device Manufacturer Date | 2014-08-28 |
| Date Added to Maude | 2016-04-27 |
| 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 | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628063 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAMSHIDI NEEDLE BONE MARROW 13GX3.5 ASP |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2016-04-27 |
| Returned To Mfg | 2016-04-18 |
| Model Number | DJ3513X |
| Lot Number | 0000694947 |
| 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. Other | 2016-04-27 |