MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-01-27 for MEDICAL ACTION INDUSTRIES 267014 manufactured by Medical Action Industries.
[36930025]
Mai received the medwatch (b)(4) report detailing patient injury on (b)(6) 2016. Upon receipt, mai followed up with the hospital for a complete description of incident and details related to the patient well-being and devices involved. The hospital informed mai that the applicator involved in the incident was returned to the component manufacturer carefusion. Carefusion reports to mai that it has conducted an investigation of the applicator. The investigation indicated there was no presence or evidence of any foreign material and that there was no issues observed. The inside cavity of the product was opened and there was no damage found. The production records were reviewed and no non-conformances were noted. No root cause was able to be confirmed and no additional complaints have been received related to this issue.
Patient Sequence No: 1, Text Type: N, H10
[36930026]
On 01/05/2016, medical action industries (mai), (b)(4), received medwatch (b)(4) which indicated a patient suffered an injury associated with the use of chloraprep. A nurse at (b)(6) hospital reported using the chloraprep to prep a patient for iv insertion when she noted two linear abrasions to the patient's right antecubital area as a result of using the chloraprep. The hospital returned the affected component to carefusion (the component manufacturer) for evaluation and investigation. The area was cleaned and gauze bandage applied by nurse at the time of the incident. The chloraprep frepp 1. 5ml applicator involved (lot: 88663) was manufactured by carefusion. The component was included in a mai-manufactured convenience kit 267014, iv start kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030451-2016-00003 |
| MDR Report Key | 5394220 |
| Report Source | USER FACILITY |
| Date Received | 2016-01-27 |
| Date of Report | 2016-01-27 |
| Date of Event | 2015-11-19 |
| Date Mfgr Received | 2016-01-05 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2016-01-27 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 28704 |
| Manufacturer Country | US |
| Manufacturer Postal | 28704 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICAL ACTION INDUSTRIES |
| Generic Name | IV START KIT |
| Product Code | LRS |
| Date Received | 2016-01-27 |
| Model Number | 267014 |
| Catalog Number | 267014 |
| Lot Number | 213752 |
| Device Expiration Date | 2018-06-30 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2016-01-27 |