Alleged event: after insertion of the catheter, when the nurse put tape on the patient's body, a cut was found in the catheter.As a result, the catheter was replaced by a new one.The patient's condition was reported as fine.
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(b)(4) a device history record review was performed on the catheter with no findings relevant to this complaint.The customer reported the catheter was discovered cut during use.The customer returned one epidural catheter, one snaplock adapter with clamp, and one flat filter.The snaplock adapter, filter, and piece of the separated catheter were received connected together (b)(4)).The catheter was returned separated in two pieces.The returned components were visually examined with and without margination.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned filter revealed that the filter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears used in that there is biological material present between the catheter coils.Microscopic examination revealed that the catheter appears to have been cut.The point of separation on either catheter piece shows no signs of stretching and the inner coil wire remains tightly wound).No other defects or anomalies were observed.Other remarks: the returned catheter pieces were measured ((b)(4)).The two catheter pieces measured approximately 50.5cm & 40.3cm.Specification per graphic (b)(4) indicates that the catheter length must be between 88.5-91.5 cm.The returned catheter pieces add up to a cumulative measurement of 90.8cm.No signs of catheter stretching were present on the catheter extrusion or inner coils.This indicates the entire catheter was returned and no pieces are missing.Specifications per graphic (b)(4) were reviewed as a part of this complaint investigation.The ifu for this product,(b)(4) , was reviewed as a part of this complaint investigation.The ifu warns the user, "do not alter the catheter or any other kit/set component during insertion, use, or removal (except as instructed)." a corrective action is not required at this time as the condition of the sample received and the time of discovery indicate that use error caused or contributed to this event.The reported complaint of a cut catheter was confirmed based on the sample received.The returned catheter was returned in two pieces.The damage observed at the point of separation for both catheter pieces was consistent with a catheter that has been cut.The ifu for this kit, (b)(4), instructs the user not to alter the catheter.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, based upon the information provided, the observed catheter damage, and the time of discovery, use error caused or contributed to this event.
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Alleged event: after insertion of the catheter, when the nurse put tape on the patient's body, a cut was found in the catheter.As a result, the catheter was replaced by a new one.The patient's condition was reported as fine.
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