MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-01-19 for SLINGS, CLIP MLAAS2000-M-L1 manufactured by Arjohuntleigh Polska Sp. Z O.o..
[65232847]
(b)(4). An investigation was carried out into this complaint. Arjohuntleigh received a complaint where it was indicated that stitching inside of the red loop of the sling failed based on the information received. No injuries and no patient involvement was reported. 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. It has been established that the sling was not being used for patient handling at the time of the event. During our investigation the sling was found red loop stitching inside loop failed and was found to not have been to specification. The sling was not in use at the time for patient 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 this sling, especially since one of attachment points of the loop was broken. Therefore, the sling showing signs of unstitching, should be withdrawn and replaced. After reviewing the complaint it comes forward that the loop breakage appears most likely to occur as follows: 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 the 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. Since the loop break is indicated to have occurred outside of use, it may have been caused even by becoming stuck during the mechanical washing or drying process. After this review, we can state the event outcome of the breaking off the loop, is not likely to happen when following the device labeling or the instructions for use (ifu). 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 stress that is not likely to be encountered during on label use. We find this complaint to be reportable to the competent authorities in the abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[65232848]
On (b)(6) 2016 arjohuntleigh received a customer complaint where it was indicated that stitching inside of the red loop of the sling failed based on the photographic evidences received. No injuries and no patient involvement was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00014 |
| MDR Report Key | 6263118 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-01-19 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-12-22 |
| Date Facility Aware | 2016-12-22 |
| Report Date | 2017-01-19 |
| Date Reported to FDA | 2017-01-19 |
| Date Reported to Mfgr | 2017-01-19 |
| Date Mfgr Received | 2016-12-22 |
| Device Manufacturer Date | 2016-08-16 |
| Date Added to Maude | 2017-01-19 |
| 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 CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 4869828246 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, PL-62052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | PL-62052 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLINGS, CLIP |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2017-01-19 |
| Model Number | MLAAS2000-M-L1 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 16 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Address | UL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI, PL-62052 PL PL-62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-19 |