MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-09-17 for IV START KIT 68917 manufactured by Medical Action Industries.
[26034783]
Upon receipt of the complaint received (b)(6) 2015, mai opened internal (b)(4), to further investigate and initiate appropriate corrective/preventive actions. Mai issued a supplier corrective action report, (b)(4), to the manufacturer/supplier, (b)(4), on (b)(6) 2015 to further address this component issue. (b)(4) has indicated communication with the end user to directly obtain the applicator for investigation purposes. Mai was only able to investigate pictures, current inventory supply, and trending records for internal investigation. Mai trending analysis found no other complaints received this year that were similar in nature and current inventory sampling was acceptable. The applicator was not broken upon receipt by the end user, this glass breakage occurred during the initiation of the applicator. (b)(4) notified mai that they have offered re-education on applicator use to the healthcare facility. (b)(4) has also initiated an internal investigation into the occurrence to determine the root cause and corrective/preventive actions necessary to appropriately respond. At this time they informed mai that they are still performing investigation into the complaint and do not have a conclusion available at this time. (b)(4) has this component registered as a drug under an nda and therefore will be submitting their incident report to the fda srp portal for this injury.
Patient Sequence No: 1, Text Type: N, H10
[26034784]
Medical action industries (mai) is the manufacturer of an iv start kit (itm: 68917, iv start 100/cs) that contains a chloraprep sepp one-step applicator 0. 67ml (itm: 260441nsb, (b)(4)) manufactured by (b)(4). On (b)(6) 2015, mai received a customer complaint from froedtert & the medical college of wisconsin indicating a nurse was injured by a chloraprep sepp one-step applicator 0. 67ml contained within a mai manufactured iv start kit. The complaint states, "this morning one of our nurses was injured as a result of a glass shard penetrating the plastic applicator of a chloraprep sepp applicator that is included in our iv start kits. " the complaint states that the nurse did not activate the applicator stick any differently than previously. The hospital clarified with mai that the breakage occurred during the initiation of the applicator; the applicator was not broken upon receipt. On (b)(6) 2015, mai asked additional investigation questions to the hospital as part of the incident investigation and at this time the hospital indicated that two other similar instances had occurred in the last 3 months involving two other chloraprep sepp one-step applicators causing similar injuries to a total of two different nurses. The hospital reported that both nurses sustained injuries when glass shards punctured the plastic applicator upon activation. The glass shards punctured each nurse's thumb causing bleeding. Each excused him/herself from patient care, removed their gloves, and proceeded with basic first aid measures which included cleaning the puncture site, inspecting the injury, and placing a band-aid on the thumb. The hospital reported that both nurses recovered from their injuries. The hospital was unable to confirm that the two other incidents were chloraprep sepp applicators which were assembled in mai manufactured kits. The hospital was not able to provide specific lot, catalog or model number information for these complaints; therefore, we are including this information in one report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030451-2015-00002 |
| MDR Report Key | 5083990 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-09-17 |
| Date of Report | 2015-09-12 |
| Date of Event | 2015-08-20 |
| Date Mfgr Received | 2015-08-20 |
| Device Manufacturer Date | 2015-02-12 |
| Date Added to Maude | 2015-09-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS NICHOLE EARLY |
| Manufacturer Phone | 8283387567 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV START KIT |
| Generic Name | IV START KIT |
| Product Code | LRS |
| Date Received | 2015-09-17 |
| Returned To Mfg | 2015-08-25 |
| Model Number | 68917 |
| Catalog Number | 68917 |
| Lot Number | 205539 |
| Device Expiration Date | 2017-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2015-09-17 |