The device history record was reviewed, and no similar concerns were found.A review of the returned product was performed.Visual inspection found that the picc tubing is broken approximately 1cm from the hub.The exact root cause is unable to be determined; however, a possible cause of the catheter breakage may be related to excessive tensile/pulling force during use.There were no issues identified related to manufacture of the product.All catheters undergo (100%) inspection during manufacturing.Catheters undergo tensile strength testing, flow, leak, and burst testing to ensure the integrity of the catheter and its ability to endure use.
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