MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES IV START KIT

Model Number 68917

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: IV START KIT
• Type of Device: IV START KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer Contact: nichole early ; 8283387567
• MDR Report Key: 5083990
• MDR Text Key: 26034783
• Report Number: 1030451-2015-00002
• Device Sequence Number: 1
• Product Code: LRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Report Date: 09/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Model Number: 68917
• Device Catalogue Number: 68917
• Device Lot Number: 205539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other