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Catalog Number 77-400277 |
Device Problems
Device Dislodged or Dislocated (2923); Escape (2931)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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An internal complaint ((b)(4)) was received indicating that a syringe (finished good (b)(4), lot number iaflq1511) was malfunctioning.The customer reported the plungers became crooked, causing a loose seal and allowing contrast fluid to spill out.This was reported to have occurred in "5 or 6" syringes, and therefore, a total of five internal complaints were entered.The syringe is supplied to deroyal by (b)(4).A supplier corrective action request (scar) has been sent to the vendor.Samples were returned in connection with the initial complaint, which is associated with medical device report 1060680-2016-00019.These also were forwarded to (b)(4) for evaluation.The vendor confirmed via email july 27,, 2016, that it had received the scar request and samples.The (b)(6) scar and supplier notification letter logs were reviewed for similar complaints.None were identified.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
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Event Description
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The plunger inside of the syringe became crooked, allowing contrast to leak out of the syringe.
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Manufacturer Narrative
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Root cause: the syringe is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was submitted to (b)(4).In its response, the supplier stated the root cause cannot be determined due to a lack of information and defective samples.Corrective action: in its scar response, (b)(4) stated an awareness review was performed with employees.Investigation summary: an internal complaint ((b)(4)) was received indicating that a syringe (finished good 77-400277, lot number iaflq1511) was malfunctioning.The customer reported the plungers became crooked, causing a loose seal and allowing contrast fluid to spill out.This was reported to have occurred in "5 or 6" syringes, and therefore, a total of (b)(4) internal complaints were entered.The syringe is supplied to deroyal by (b)(4).Samples were returned in connection with the initial complaint, which is associated with medical device report 1060680-2016-00019.These also were forwarded to (b)(4) for evaluation.The vendor confirmed via email july 27, 2016, that it had received the scar request and samples.A response was received and accepted by deroyal personnel on august 23, 2016.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.None were identified.Preventive action: in its scar response, (b)(6) stated a different style of assembly fixture was created to improve plunger assembly by fully seating the plunger.The change was reviewed, and more than 100 consecutive assemblies were observed.No ill-fitting plunger assemblies occurred.(b)(4) intends to continue performing random audits over the next 90 days.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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Event Description
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The plunger inside of the syringe became crooked, allowing contrast to leak out of the syringe.
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Manufacturer Narrative
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Root cause: the syringe is supplied to deroyal industries by (b)(4).Therefore, a supplier corrective action request (scar) was issued to (b)(4).In its response, (b)(4) stated it was unable to determine a true root cause.In reviewing the returned samples, the device history record, and the fixtures used during assembly, (b)(4) confirmed the device was assembled correctly.A possible root cause is misalignment by the end user.Corrective action: in its scar response, (b)(4) stated it has issued a quality alert to raise awareness among its operators, assemblers, and inspection personnel.Investigation summary: an internal complaint ((b)(4)) was received indicating that a syringe (finished good 77-400277, lot number iaflq1511) was malfunctioning.The customer reported the plungers became crooked, causing a loose seal and allowing contrast fluid to spill out.This was reported to have occurred in "5 or 6" syringes, and therefore, a total of five internal complaints were entered.The syringe is supplied to (b)(4).Samples were returned in connection with the initial complaint, which is associated with medical device report 1060680-2016-00019.These also were forwarded to (b)(4) for evaluation.The vendor confirmed via email july 27, 2016, that it had received the scar request and samples.A response was received and accepted by (b)(4) personnel on august 23, 2016.An updated scar response was received january 31, 2017, with additional information.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.None were identified.Preventive action: in its scar response, (b)(4) stated a different style of assembly fixture was created to improve plunger assembly by fully seating the plunger.The change was reviewed, and more than (b)(4) consecutive assemblies were observed.No ill-fitting plunger assemblies occurred.(b)(4) intends to continue performing random audits over the next 90 days.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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Event Description
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The plunger inside of the syringe became crooked, allowing contrast to leak out of the syringe.
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Search Alerts/Recalls
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