The investigation revealed that prior to opening the package which contains the powder and ampoule, it was noticed that white matter was found on the case which contains the ampoule and the plastic packaging was deformed.The ampoule has most likely become damaged between leaving the manufacturing site and reaching the customer.The ampoule is broken at the neck which has resulted in the contents leaking out, leaving a dried white residue in the blister.This hazard has been identified in the dfmea, which states ¿glass ampoule breaks prematurely during transit.Monomer leaks into rest of product.Product unusable.Theatre staff have to get new pack.¿ new packaging has been put in place which has significantly reduced the amount of complaints hence indicating the change has been effective.Between january 2010 and september 2013, there were a total of (b)(4) complaints relating to broken ampoules (across all depuy acrylic based cements).A new ampoule blister was introduced around september 2012.Since december 2013, there have been 15 confirmed breakages related to the new ampoule blister.(b)(4).A dhr review found no related noncomformances.Microbiological and sterility tests passed.No similar complaints have been found for this product code or family in the last 12 months.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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