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.
Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.
A device history record could not be completed as no lot number was received.
Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.
Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
Rationale: based on the investigation, no additional investigation and no capa is required at this time.
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter was inserted into the patient on (b)(6) 2019, resulting in "phlebitis, thrombophlebitis, or dvt" after use when the catheter was removed the next day.
However, no further information was provided by the initial reporter.
This complaint was created to capture the 1st of 10 related incidents.
The following information was provided by the initial reporter: health professional called and stated facility has had 10 reports of phlebitis, thrombo phlebitis or dvt since (b)(6).
Has the dates that patients had the iv's inserted: on (b)(6) 2019, removed (b)(6) 2019.
Inserted (b)(6) 2019, removed (b)(6) 2019.
On (b)(6) 2019, inserted and removed.
Inserted (b)(6) 2019, removed (b)(6) 2019.
On (b)(6) 2019, inserted and removed.
Inserted (b)(6) 2019, removed (b)(6) 2019.
Inserted and removed (b)(6) 2019.
Inserted (b)(6) 2019, removed (b)(6) 2019.
Inserted and removed (b)(6).
Inserted (b)(6) 2019 and removed (b)(6) 2019.
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