MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,07 report with the FDA on 2014-09-03 for PORT ACCESS, KIT manufactured by Medical Action Industries, Inc..
[22067351]
Please refer to importer report#: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[22269834]
On (b)(4) 2014, medical action industries (mai) received a complaint via a sales representative that a (b)(4) blunt cannula non-coring safety needle was bent as a nurse was attempting to access the portacath. Mai does not mfr the defective needle, but does mfr the port access kit, 59043c (lots # 187966, 185508 and 189211) that contains the needle. Smiths medical mfrs the needle. Immediately upon receipt of the complaint, mai opened complaint numbers # 200016236, 200016237 and 200016238, one for each complaint lot, and began the investigation. On 08/04/2014, mai received medwatch # (b)(4) from fda. This specific needle lot # 34x136 was only used in the kit complaint lots. Mai's inventory of the specific needle lot involved and complaint kit lots was exhausted upon receipt of this complaint. Review of complaint history shows we have no additional complaints on the complaint lots. In addition, this needle is used in other kits with no complaints in regard to this concern. We do not see a trend in regard to this issue and determined the complaint to be an isolated incident. Our supplier, smiths medical, was notified of this issue, and was given samples from the customer to further address the issue. Smiths medical responded directly to the customer on (b)(4) 2014 that the samples received were within specifications of their critical diameter size dimension of the trocar/cannulas, and the bending observed was consistent with the gripper micro having been subjected to a lateral force rather than straight down. Per their instructions for use, the force should be applied at 90 degrees. Although our supplier confirmed the complaint, they found no evidence to suggest the event was caused from an intrinsic defect in the product or a mfg issue. Smiths medical's supplier eval summary is also attached. To date, all kit complaint lots have been exhausted from all facilities involved except for 15 cases of lot #189211 which has been quarantined at mai's distributor. Smiths medical has just notified the end user that they are confident there is no risk in putting the complaint needle and kits back into distribution. Mai has entered the complaint into our database and will continue to track for any related trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030451-2014-00008 |
| MDR Report Key | 4369847 |
| Report Source | 00,06,07 |
| Date Received | 2014-09-03 |
| Date Mfgr Received | 2014-08-04 |
| Date Added to Maude | 2015-01-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DEBORAH KLOOS |
| Manufacturer Street | 25 HEYWOOD RD. |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal | 28704 |
| Manufacturer Phone | 8286818820 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PORT ACCESS, KIT |
| Product Code | LRS |
| Date Received | 2014-09-03 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES, INC. |
| Manufacturer Address | 25 HEYWOOD RD. ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-03 |