MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,07 report with the FDA on 2013-05-20 for CATH LAB KIT 46096-26 manufactured by Icu Medical, Inc..
[3537604]
Fda (b)(4) received concerning leakage issues with use of one 46096-26 cath lab kit. The (b)(4) report states the 46096-26 cath lab kit's "... Manifold leaked around control syringe. New manifold dropped into sterile field. Equipment removed from the sterile field. New sterile manifold opened and used without patient harm. " although requested, the involved 46096-26 cardiac cath kit and/or same lot samples were not returned to the manufacturer for analysis and confirmation.
Patient Sequence No: 1, Text Type: D, B5
[10830998]
Manufacturer's investigation: a review of the manufacturing database for the reported lot number 2559304 (mfg date: 09/01/2012) shows (b)(4) units were manufactured, tested, inspected and released. There were no exception documents generated during the lot build. Conclusion: the involved 46096-26 cardiac cath kit was not returned for analysis and confirmation. The exact cause of the problem is unk. This complaint and associated info have been entered in the manufacturer's database for analysis and trending. Manufacturing lot records were reviewed; complaint trending analysis performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025816-2013-00052 |
| MDR Report Key | 3151875 |
| Report Source | 00,05,06,07 |
| Date Received | 2013-05-20 |
| Date of Report | 2013-02-27 |
| Date of Event | 2013-02-06 |
| Date Facility Aware | 2013-02-06 |
| Report Date | 2013-02-27 |
| Date Reported to FDA | 2013-02-27 |
| Date Reported to Mfgr | 2013-03-14 |
| Date Mfgr Received | 2013-03-14 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2013-06-11 |
| 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 | TERRY SCESNY |
| Manufacturer Street | 4455 ATHERTON DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012641400 |
| Manufacturer G1 | ICU MEDICAL, INC. |
| Manufacturer Street | 4455 ATHERTON DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATH LAB KIT |
| Generic Name | CARDIAC CATH KIT |
| Product Code | OES |
| Date Received | 2013-05-20 |
| Model Number | 46096-26 |
| Catalog Number | 46096-26 |
| Lot Number | 2559304 |
| ID Number | PR#17184 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | SALT LAKE CITY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-20 |