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Correction: e1 - customer person: postal code: (b)(6), phone: (b)(6).Investigation ¿ evaluation: (b)(6) hospital, in australia, informed cook that on (b)(6) 2021 the hub on an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter from lot 8888816 separated from the catheter.The drain had been placed in a 48-year-old male patient to drain a ¿small¿ pneumothorax after a lung biopsy.The user reported that the drainage catheter was inserted using the seldinger technique without any complications.The patient was transported to a medical ward for continued care.It was reported that during sleep, the patient rolled over and the hub of the catheter disconnected.Medical personnel clamped the catheter to prevent anymore air from entering the lung.It was determined that the patient suffered a complete pneumothorax and returned to the angiography suite where another similar device was placed to continue treatment of the collapsed lung.No other adverse events were reported for this incident.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The customer returned one used and separated 10.2ult catheter.The mac-loc assembly is separated from the catheter tubing, and the catheter has been cut on the distal end.The proximal catheter flare is intact.The appropriate number of threads are showing between the cap and adapter.The connector cap inner diameter is within specification.Additionally, a document based investigation evaluation was performed.The risk specifications covering mac-loc drainage catheters includes hub separation as a potential failure mode.The identified risk controls include the manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.Based on the review of current documentation, it was concluded that inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot records no related nonconformances.A complaint history search found no additional complaints from the lot.Therefore, there is no evidence of nonconforming material in house or in the field.A capa was previously opened for this product issue.The capa investigation implemented corrective actions related to manufacturing and quality control.Because this lot was manufactured prior to corrective action implementation, the cause of this event is manufacturing and quality control deficiency as determined from the capa investigation.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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