COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
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Catalog Number ULT8.5-38-40-P-32S-CLB-RH |
Device Problems
Leak/Splash (1354); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Code Available (3191)
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Event Date 11/02/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
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Event Description
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The complainant reported that the physician placed a biliary drain in a patient and the patient came back 24 hours later to have the drain replaced, as the drain was leaking.The physician opened up another 8fr (french) package and noted that there was a 10fr hub on the device.The physician looked at both the removed device and the new device believing they were two 10fr devices packaged in 8fr pouches with 8fr labels.Both labels reportedly showed 8fr and the drains inside were reportedly 10fr with10fr hubs.These devices were also had the same lot number.The physician was "okay" using the 10fr drains.The doctor believed the devices were 10fr drains.However, it was later confirmed that the actual size of the removed device was 8 french, as it was labeled on the packaging, but the stamp on the hub itself was incorrectly labeled for a 10 french device.There were no reports of any section of the device remaining inside the patient's body and the initial reporter noted that the patient did not experience any adverse effects as a result of this product problem.
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Search Alerts/Recalls
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