H10: manufacturing review: the lot number for the device was not provided; therefore, a review of the device history records could not be performed.Investigation summary: one plastic powerport isp m.R.I.Implantable port with 8 fr s/l power groshong catheter was returned for evaluation.The sample had blood staining and fluid residue throughout and showed to be the port with a 6.7 cm length of interim power tubing inlaid under the cath-lock on the port stem and detached 14.8 cm length of distal power tubing.Initial examination of the proximal segment showed multiple access and slits of the port septum, a definitive curve in the interim tubing and the depth markings clear with a partial circumferential crack between the 15/16 cm depth markings.Initial examination of the detached tubing segment showed a definitive curve, the depth markings clear with an inclined suture crease between the 9/10 cm depth markings.The tactile evaluation showed necking of tubing at the stress, crease marks and crack sites.The complete circumferential break had smooth edges on the sides and rough edges at the top and bottom of the break.The investigation is confirmed for the break and leak, specifically caused by flexural fatigue.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: g4, h6 (device code 2889) h11: h3, h6 (device), h6 (results, conclusion) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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