Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The complaint was deemed as mdr reportable therefore a submission will be performed.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.
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It was reported that bd insyte¿ autoguard¿ shielded iv catheter was used and the patient had an allergic reaction.This was discovered after use.The following information was provided by the initial reporter: material no.381433, batch no.Unknown.It was reported that health professional stated that facility has had 10 reports of phlebitis, thrombo phlebitis or dvt since january.Health professional called and stated facility has had 10 reports of phlebitis, thrombo phlebitis or dvt since january.Has the dates that patients had the iv's inserted.Inserted (b)(6) 2019, removed (b)(6) 2019.By the time they noticed an issue they weren't recording lot numbers.
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