MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-13 for PORT ACCESS KIT 59043C manufactured by Medical Action Industries.
[28512644]
Since the complaint component itself is not manufactured by mai and the customer was unable to provide a sample or photo for evaluation, the investigation into this complaint was limited. The raw material lot 34x861 for this complaint was exhausted from mai current inventory at the time of complaint receipt. Mai did assess its complaint database for any related complaints or trends. This component and lot number is only involved in the mai manufacture of two different convenience kits for which there have been no other complaints received from any other customers. This same customer had a related complaint in 2014 on the same component but it was a different raw material lot. In 2014, the manufacturer performed an investigation based on two received samples from the hospital. The manufacturer investigation at that time concluded that the insertion technique used by the hospital contradicted step #3 of the instructions per use (ifu), which states the device must be applied at 90 degrees. The manufacturer found no evidence that the event was caused by an intrinsic defect in the product itself. The manufacturer offered to meet with the hospital and nurse educators to demonstrate appropriate device technique for use and explain further the cause of these events. Mai notified (b)(4) of this subsequent complaint on september 23, 2015. (b)(4) will be performing their own internal investigation into this issue. At this time however, mai? S investigation is limited due to lack of samples or photos to further explore.
Patient Sequence No: 1, Text Type: N, H10
[28512785]
Micro gripper needle bent when accessing portacath. Medical action industries (mai) is the manufacturer of a port access kit containing a component that was the subject of a letter received september 16, 2015 from fda enclosing medwatch, (b)(4). The medwatch reported an issue with port access kit (59043c) component, gripper micro needle, recorder# 21-3277-24, lot#34x861, purchased from and supplied by (b)(4). The report was filed by (b)(6). The facility reports that a gripper micro needle bent when attempting to access a patient's portacath. The facility stated this instance was similar to an instance reported last year (1030451-2014-00008); however, this is a different lot number associated. The gripper micro needle presently involved was (b)(4) gripper micro: reorder # 21-3277-24, lot #34x861. There was no known patient injury associated with the bent gripper micro needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030451-2015-00004 |
| MDR Report Key | 5145700 |
| Date Received | 2015-10-13 |
| Date of Report | 2015-10-12 |
| Date of Event | 2015-02-03 |
| Date Mfgr Received | 2015-09-16 |
| Date Added to Maude | 2015-10-13 |
| 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 | NICHOLE EARLY |
| Manufacturer Street | 25 HEYWOOD ROAD |
| Manufacturer City | ARDEN NC |
| Manufacturer Phone | 8283387568 |
| Manufacturer G1 | MEDICAL ACTION INDUSTRIES |
| Manufacturer Street | 25 HEYWOOD ROAD |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PORT ACCESS KIT |
| Generic Name | PORT ACCESS KIT - PERIPHERAL CATHETER INSERTION KIT |
| Product Code | OWL |
| Date Received | 2015-10-13 |
| Catalog Number | 59043C |
| Lot Number | UNKNOWN |
| Device Expiration Date | 2016-05-01 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES |
| Manufacturer Address | 25 HEYWOOD ROAD ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-13 |