SMITHS MEDICAL ASD, INC. JELCO PLUS STRAIGHT CONVENTIONAL CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
|
Back to Search Results |
|
Model Number 7063 |
Device Problem
Difficult to Insert (1316)
|
Patient Problem
Needle Stick/Puncture (2462)
|
Event Date 09/06/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Udi section is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
|
|
Event Description
|
A catheter required three attempts to cannulize the patient correctly.Insertion felt forced and damaged the venous area.Customer response received on (b)(6) 2022: no further information is known.
|
|
Manufacturer Narrative
|
No product or photographic evidence were provided to aid in this investigation.As a result, a complaint investigation / product evaluation and problem confirmation cannot be performed.The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
|
|
Search Alerts/Recalls
|
|
|