MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-09-17 for MAI I.V. KIT 69581 manufactured by Medical Action Industries, Inc..
[3908065]
Registered nurse was prepping the patient for an i. V. Using a carefusion brand chloraprep frepp from an mai brand iv start kit. While registered nurse was scrubbing the arm to clean off area, the patient stated it was hurting. Upon examination, the patient's arm had scratches all over from choloraprep glass. The registered nurse tried to sponge the area, but glass shards protruded from the frepp device and cut the patient. Basic first aid was provided: site cleaned and dressed. No harm to the healthcare provider.
Patient Sequence No: 1, Text Type: D, B5
[11139149]
Medical action industries inc. (mai) received a complaint from (b)(6) on (b)(4) 2013 for a patient injury caused by a chloraprep frepp device, lot #62696. Other than cleaning and dressing the scratches, no further treatment was required. Mai immediately opened complaint (b)(4) to begin the investigation. On (b)(4) 2103, mai received medwatch (b)(4) for the same incident. Mai does not manufacture the incident device, the chloraprep frepp applicator, but did manufacture the iv kit #69581, lot #167964 containing it. Carefusion manufactured the complaint frepp device. Due to this, mai issued scar (b)(4) (supplier corrective action request) to carefusion that required them to perform an investigation and determine root cause(s) and corrective/preventive actions. Their scar response was received dated (b)(4) 2013. A carefusion representative has visited the hospital to address the issue with the staff. Mai's inventory of the complaint lots for both kit and applicator has been exhausted. No additional complaints have been received for either the kit or applicator lots involved in the complaint. The sample is not available for examination. Carefusion has sent a letter dated (b)(4) 2013 (based on their scar) to the customer that included the statements: "this type of incident is extremely rare; however, it is conceivable that if a glass shard aligned correctly against the foam, it is sharp enough to pierce through the novenette liner. Glass can be pushed against the foam if the wings of the frepp are repeatedly squeezed in an attempt to promote the flow of the solution. " carefusion also offered for their representative to meet with the hospital staff to provide re-education. Mai will maintain the carefusion scar response on file. Any additional information that carefusion might be able to provide will be communicated to the complainant. Additionally, this complaint has been entered into our post-market surveillance system for appropriate tracking, trending and any required follow-up per our standard procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030451-2013-00005 |
| MDR Report Key | 3421027 |
| Report Source | 00,05 |
| Date Received | 2013-09-17 |
| Date of Report | 2013-09-16 |
| Date of Event | 2013-08-19 |
| Date Mfgr Received | 2013-08-19 |
| Date Added to Maude | 2013-11-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEBORAH KLOOS, DIRECTOR |
| Manufacturer Street | 25 HEYWOOD RD. MINOR PROCEDURE KITS AND TRAYS SBU |
| 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 |
| Brand Name | MAI I.V. KIT |
| Generic Name | I.V. START KIT; I.V. KIT; CONVENIENCE KIT |
| Product Code | LRS |
| Date Received | 2013-09-17 |
| Model Number | 69581 |
| Catalog Number | 69581 |
| Lot Number | 167964 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2013-09-17 |