MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-11-21 for OLD 5ML CLR EXACTAMED EMEA (H9381105) manufactured by Baxter Healthcare Corporation.
[15271033]
Technical support received an e-mail from baxter emea quality regarding a complaint from the (b)(6) customer on (b)(6) 2013. The complainant stated that an oral drug was administered via an iv line using baxa 5 ml oral syringe. No patient harm occurred.
Patient Sequence No: 1, Text Type: D, B5
[15663545]
Method code: actual device not evaluated. Technical support received an e-mail from baxter emea quality regarding a complaint from the united kingdom's customer on october 31, 2013. The complainant stated that an oral drug was administered via an iv line using baxa 5 ml oral syringe. No patient injury or illness reported. There are no samples available for an evaluation. We have conducted an investigation into this issue and have determined that our dispensers, old 5ml clr exactamed emea (h9381105) meet specifications and requirements of npsa patient safety alert npsa/2007/19. We have determined the root cause of this issue is a result of bd nexiva needleless adapters not meeting the iso 594 standards. A worldwide voluntary recall was announced by bd on october 28, 2009, for bd q-syte luer access devices and bd nexiva closed iv catheter systems may have further contributed to the cause of the incident. Our risk assessment of these reported issues show that the potential of patient harm is sufficiently low due ot the following risk control measures: 1. Oral dispensers are clearly labeled for oral or enteral use only. 2. The clear dispensers have purple plungers specifically to comply with npsa alert 19 so that they are identified for oral/enteral use. 3. Our dispensers comply with iso 80369-annex b standards to not activate any needleless connector that is designed to iso 594 standards. Based on an evaluation of the product risk management files for these dispensers, this issue is not occurring with greater frequency or severity than anticipated for the device. Device was not available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419106-2013-00014 |
| MDR Report Key | 3482217 |
| Report Source | 06 |
| Date Received | 2013-11-21 |
| Date of Report | 2013-10-31 |
| Date of Event | 2013-10-31 |
| Date Mfgr Received | 2013-10-31 |
| Date Added to Maude | 2014-03-04 |
| 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 | MS. PHONE VANG |
| Manufacturer Street | 9540 S MAROON CIRCLE # 400 |
| Manufacturer City | ENGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal | 80112 |
| Manufacturer Phone | 3037846639 |
| Manufacturer G1 | BAXTER HEALTHCARE |
| Manufacturer Street | 14445 GRASSLANDS DRIVE |
| Manufacturer City | ENGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80112 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLD 5ML CLR EXACTAMED EMEA (H9381105) |
| Generic Name | OLD 5ML CLR EXACTAMED EMEA (H9381105) |
| Product Code | KCP |
| Date Received | 2013-11-21 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | 9540 S MAROON CIRCLE # 400 ENGLEWOOD CO 80112 US 80112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-21 |