The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the retainers detached from the statlock pads is confirmed and appears to be manufacturing related.The products returned for evaluation were 13 unopened statlock kits and two opened statlock kits.One of the returned opened kits (sample 1) was returned with the retainer still attached to the foam pad.When an attempt was made to remove the retainer from the pad, the retainer appeared to be adhered to the foam pad around the entire perimeter.The foam pad could be seen tearing when the retainer was pulled, indicating that the retainer had been properly adhered to the pad.The other opened kit (sample 2) was received with the retainer completely detached from the foam pad.Only a small amount of the pad had torn in the lower left-hand corner of the retainer.A small amount of adhesive was seen on the retainer in this location but was not visible on the rest of the perimeter of the retainer.The statlocks in both sample 1 and sample 2 appeared unused as the samples were free of residual material and the paper backing had not been removed from the foam pads.The retainers were attached to the pads on all of the unopened statlock devices.The unopened kits were opened, and an attempt was made to lightly manipulate the retainers to see if they easily removed from the statlock pads.Five of the thirteen unopened samples had retainers that easily separated from the foam pad on the bottom edge on at least one side.The samples did not appear to have a full adhesive transfer between the retainer and pad.The other eight unopened samples showed an even adhesive joint between the retainer and the pad.The retainers did not separate easily from the pads.As the device broke prior to use, the root cause is likely manufacturing related.Possible contributing factors could include an insufficient amount of adhesive, adhesive in an incorrect location, or an improper cure of the adhesive.Bd is working closely with manufacturing to help prevent recurrence of the reported event.A lot history review (lhr) of jues2901 showed five other similar product complaint(s) from this lot number.The complaints for this lot number (jues2901) have been reported from the same facility in (b)(6).
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