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Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown.Occupation: clinical product evaluation coordinator.Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Additional information: d10 ¿ product received on (b)(6) 2019.Investigation - evaluation a review of the complaint history, instructions for use, manufacturing instructions, and quality control, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One 5 fr double lumen catheter was returned for evaluation.The catheter was not abrm coated.Two identical needleless connectors were attached to both hubs and were made of blue and clear plastic.Biomatter was present throughout the device; specifically within the extension tubes, on the hubs and within the suture wing manifold.Green discoloration was observed within the needleless connectors.Kinks were observed where the blue clamps attach to the extension tubes.There was no damage observed on the white hub (lumen #1), however, a slight blue-green discoloration was noted on the luer lock.This discoloration was consistent with the needleless connector attached.A crack was observed on the blue hub (lumen #2) 8mm from the luer lock end.The crack was parallel with the wing, opposite side of the gate.No additional damage was observed on the blue hub.A leak test was performed on both hubs using a 20cc syringe.The white hub was successfully flushed with no leaks.After an attempt to flush the blue hub, water was found to be leaking through the hub crack.Additionally, a document-based investigation evaluation was performed.It was concluded that there are sufficient inspection activities in place to identify this failure mode prior to distribution.A review of the device history record could not be completed, as the lot information is unknown.As adequate inspection activities have been established, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions ¿¿do not re-sterilize catheter.Do not cut, trim or modify catheter or components prior to placement or intraoperatively.¿ how supplied ".Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." the investigation found that the affected component was supplied to cook by a supplier.A supplier investigation was not requested, as the exact lot and oem part # were unknown based on the lack of information available.However, a supplier investigation involving a similar product and similar event was referenced.Per pr244950 (medwatch report # 1820334-2018-03088), the supplier reviewed manufacturing logs of hub lots.No anomalies were noted in the manufacturing process, and parameters were within validated manufacturing specifications.No evidence exists to assume parts do not meet specifications.Inspections performed during manufacturing yielded no parts out of specification.The supplier stated that there was no known relationship of the device to the reported event.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a definitive root cause could not be established.Appropriate measures are being taken to address this failure mode.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified and we 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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Additional information was received on 19mar2019.The customer stated that a baggie with the device from picu was received with a small note that states "cracked hub of blue lumen13-31-18".It is unknown if any unintended section remained in the patient's body, if the patient required any additional procedures due to the occurrence or if it contributed to the need for additional procedures, or if any adverse effects were experienced.It is unknown if any medical /surgical intervention was performed due to the experienced difficulty.The customer is unsure of the gpn or lot number of the device, as no packaging was received.The customer did state that the complaint device was not reprocessed for another use prior to this occurrence.Customer confirmed that the event occurred on (b)(6) 2018.Supply chain at the facility received the device on 01feb2019.
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Blank fields on this form indicate the information is unknown, unchanged or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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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