It was reported that the syringe 5ml ll 21ga 1-1/4in mx bun experienced damaged or open unit packaging/seal where sterility was compromised.The following information was provided by the initial reporter: 5ml bd syringe 21x 32 1 pc, lot 9338572, expiry date: 11/24.Packing with wrong cut.
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H6: investigation summary: photos received for investigation, the image shows a 5 ml syringe with the bister paper damage, where a cut in the shape of a zig zag can be observed, the cut is seen at the height of the plunger.A device history review was conducted for lot number 9338572 no quality events records in the product manufacture were found, the batch was inspected and later released accordance with the valid work instruction.Based on the photograph received, it can be concluded that the reported defect is not originated during the manufacturing process, since the cutting patterns shown in the photograph (zigzag) are not similar to the cutting patterns of the process (linear).The defect is not confirmed, therefore there is no root cause or corrective actions.H3 other text : see h10.
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