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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a statlock retainer detachment is confirmed but the exact cause remains unknown.Three photo samples of a statlock securement device were provided for evaluation.The statlock adhesive pad is shown to be attached to the patient¿s right arm near the catheter insertion site.The catheter is secured within the detached retainer and is being held by the clinician.One of the photos shows a statlock picc plus kit.The product label information indicates lot: juep1033.The conditions of use are unknown.Based on the description of the reported event, possible contributing factors include damage during handling and material degradation.Since the retainer was observed to be detached, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.
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