Medical device expiration date: unknown (b)(6).Device manufacture date: unknown.Investigation summary: 1 photo was returned for investigation.From the returned photo, it was observed that the fluid was leaking from the injection port.However, it is unclear where the leak is coming from.Investigation conclusion: 1 photo was returned for investigation.It was observed that the fluid was leaking from the injection port.The complaint is confirmed and product is out of specification.Root cause description: therefore the root cause cannot be determined.Rationale: the root cause cannot be determined.Complaint will be monitored.Based on cid #854848, capa is not required.
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It was reported that after use of the venflon pro safety 18ga 1.3mm od 45mm l there was leakage at the injection port.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: doctor, connected the iv catheter vps in the operating theatre to an infusion.The injection port, according to the customer, was not used.After a short time (duration unknown) there was a leak of blood through the injection port.The infusion was taken away and a combi stopper was connected.
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