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Model Number N/A |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Pain (1994)
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Event Date 11/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4): we received no sample nor some relevant / significant pictures for investigation.Device history record (dhr): unable to review the device history record as the reported batch number 19e25gb839 and article 4253590-03 does not match in our sap system.Complaint analysis: the situation described hard to pull; after pulling out, checked the hose and found that there were two barbs on the head of the hose.The actual sample or picture of the event was not able to be retrieved to confirm the reported defect.We assumed the capillary had tear off during pulling out.Review manufacturing process the introcan safety product is assembled on automated assembly machine equipped with vision system and test stations.All the in-line test equipment is subject of a frequent calibration and a regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected in time and would be mitigated immediately.Manufacturing control: besides the in-line machines, in process quality controls and final quality controls will perform checks and tests based on random samples.Herewith any systematic product defect would be detected.Referring to ifu: there is possibility that the catheter could be cut off as communicated in ifu: warning section stated that: after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off, leading to catheter embolism.Do not bend the catheter/needle during insertion, advancement, or removal of the needle.Extreme care should be taken not to cut the catheter and possibly cause an embolism.Conclusion: as the sample or picture was not available, further evaluation was not possible.As batch and article reported does not match, we could not review the manufacturing record.Complaint is therefore not confirmed.This report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
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Event Description
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As reported by the user facility ((b)(4)): hard to pull the pregnant woman, pregnant 18 + 1 weeks, was hospitalized due to abdominal pain, and needed to be treated with antibiotic infusion.Considering the repeated infusion of antibiotics on a regular basis, the indwelling needle was inserted.After the vein was evaluated, the left dorsal hand vein was selected.The needle was smoothly inserted and the core of the indwelling needle was smoothly withdrawn.The injection site was observed to be free of swelling and the fluid infusion was not dripping.Therefore, the indwelling needle hose was ready to be pulled out and re inserted.At this time, the hose could not be pulled out when it was withdrawn to the head.The pregnant woman complained of severe pain.The anesthesiologist, delivery room director and chief midwife were immediately informed, and then the delivery room director evaluated.After local anesthesia with lidocaine carbonate, the indwelling needle hose was pulled out.After pulling out, checked the hose and found that there were two barbs on the head of the hose.
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Search Alerts/Recalls
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