MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. SLINGS, LOOP

Model Number MLA2000-L

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Arjohuntleigh received a complaint indicating that stitching inside of the red loop of the sling failed based on the info gathered.No injuries and no pt involvement was reported.

Manufacturer Narrative

An investigation was carried out into this complaint.When reviewing similar reportable events, we have found a number of cases with similar fault description (loop stitching inside loop failed).The trend observed for reportable complaints with this failure mode is currently considered to be low and stable and slightly increasing.It has been established that the sling was not being used for pt handling at the time of the event.During our investigation the sling was found with red loop stitching inside loop failed and was found to not have been to specification.No info was received regarding the left device, which was used with this sling.However, the sling or system was not in use at the time for pt care and it did not cause or contribute to an adverse event, but it is the focus of our report and investigation.Tests carried out during the development of the sling and in current production on every sling manufactured would indicate the stitching of the loops meets the oem specification.A proper inspection of the sling should have detected the failure of these slings, especially since one of attachments points of the red loop was broken.Therefore these slings showing signs of unstitching should be withdrawn and replaced.After reviewing the complaint it comes forward that the loop breakage occurs in general ways: as the pressure on the sling loop, in the opposite direction of that experienced in normal use which can be caused by the caregiver pulling loops that way by hand or a much higher strain where the loop/sling becoming caught in an obstruction.This appears to be an indication of the loop being broken due to the application of outside force that causes the break.After this review, we can state the event outcome of the breaking of the loop is not likely to happen when following the device labeling or instructions for use.The sling is not likely to fail during the intended correct use as described in the ifu, but that a failure can occur during a use error.We find it likely that the loop broke due to the loop suffering stres that is not likely to be encountered during on-label use.From this eval it would appear most likely that the event was caused by the user not following the ifu due to a lack of awareness of the ifu contents.We find this complaint to be reportable to the competent authorities based on the initial indications and in the abundance of caution.(b)(4).

• Brand Name: SLINGS, LOOP
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan ; PL
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 0000 6205; PL 000062052
• Manufacturer Contact: pamela wright ; 12625 westmore ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4746242
• MDR Text Key: 5823460
• Report Number: 3007420694-2015-00093
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/30/2015,04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MLA2000-L
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2015
• Distributor Facility Aware Date: 04/08/2015
• Device Age: 2 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/30/2015
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other