MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-10-14 for JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP manufactured by Carefusion.
[5091231]
Packaging crumbling.? Doctor stated that after using a needle in the crumbled package the patient developed a cellulitis infection at the bone marrow site. "cellulitis at bone marrow site, don? T know if direct correlation. " additional information received on (b)(4) 2014 via (b)(4) from (b)(6): medical intervention to the patient was antibiotic administration. Outcome was uncomplicated resolution. We have samples available for evaluation (quantity? (b)(4) from (b)(4) distinct lot numbers).
Patient Sequence No: 1, Text Type: D, B5
[12418236]
(b)(4). Upon carefusion's investigation, a follow up medwatch will be submitted. Please note: lot numbers also reported by customer as potential affected product are: d11030036, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33000617]
(b)(4): seventeen (17) samples were received: nine (9) from lot# 0000310164, four (4) from lot# d11030036, two (2) from lot# d10050760, one (1) from lot# d09111607 and one (1) from lot# d10050791. In all 17 cases, fragility and tearing of the package could be noted. Failure mode could be confirmed. A review of the internal manufacturing device record for the reported lot numbers was performed and it was confirmed that procedural and functional requirements needed for their release were met. Material is considered to be related to reported failure mode. The most probable root cause could be related to material provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2014-00040 |
| MDR Report Key | 4169195 |
| Report Source | 06 |
| Date Received | 2014-10-14 |
| Date of Report | 2014-12-29 |
| Date of Event | 2014-09-26 |
| Date Mfgr Received | 2014-09-26 |
| Date Added to Maude | 2014-10-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION 203 LTD |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS KM 22 E-1 |
| 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 11GX4 ASP |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2014-10-14 |
| Lot Number | D10050761,D10050760,0000310164 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-14 |