Catalog Number CLR602 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional information was requested and the following was received.Please clarify how the primary package was violated.In the opening of the box, secondary packaging, an opening was observed in the primary packaging, compromising the sterility.Did the packaging appearance have visible defects, discoloration or cosmetic issues (not including labeling or stain), package integrity is intact? the packaging was not intact.Was there any hole, tear, or puncture that compromises sterility? yes, there was.Was there damage to the primary package that does not compromise sterility? no, the damage compromises the sterilization of the product.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
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Event Description
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It was reported that a patient underwent an unknown procedure on (b)(6) 2016 and topical skin adhesive was used.Before use on the patient, while opening the box or the secondary packaging, an opening was observed in the primary packaging, compromising the sterility.The packaging was not intact.The device was not used on the patient.There were no adverse patient consequences.
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Manufacturer Narrative
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The actual sample was returned for evaluation.Visual evaluation shows damage in the corner and the middle of the shelf box.Evidence of crack marks indicate that the shelf box suffered damages.Visual inspection shows that the tray packages are closed and sealed.Damage is observed in the tyvek lid.Evidence indicates that the sample suffered damages (blow) directly where the mesh dispenser resides, since a hole is observed in the tyvek lid.The hole on the tyvek lid is in the same position, which suggests that the impact received in the shelf box could have resulted in the mesh dispenser moving inside the package and damaging the opposite tyvek lid since the samples are packed back to back in the shelf box.Also, evidence of damage caused by a possible blow is observed on the hand leader of the mesh dispenser.A broken ampoule was also observed inside the pen body.Based on the evaluation results, it is not possible to determine: where, when or what caused the blister to suffer such damage, that the ampoule has broken and the formulation has dried due to the impact received on the shelf box.
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Search Alerts/Recalls
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