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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD YELLOW-STRIPED ADMINISTRATION SET; INFRACLAVICULAR NERVE BLOCK CATHETER
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SMITHS MEDICAL ASD, INC. CADD YELLOW-STRIPED ADMINISTRATION SET; INFRACLAVICULAR NERVE BLOCK CATHETER Back to Search Results
Catalog Number 21-7339-24
Device Problems Improper or Incorrect Procedure or Method (2017); Packaging Problem (3007)
Patient Problem Toxicity (2333)
Event Date 04/29/2016
Event Type  malfunction  
Event Description
A status-post car accident sustained a serious right arm degloving injury from shoulder to wrist.Pain service had regional block placed for post-op pain management.Started out with a an intrascalene catheter, and changed to intraclavicular with bupivacaine 0.25% continous infusion.The device was changed out to an infraclavicular catheter (the administration set used to have a label with black bold print indicating that it was an epidural catheter and the currents sets do not.The yellow stripe becomes visible if you turn the tubing a certain way and the previous tubing used to be stiffer, where this tubing is more pliable.Had a label come with the set, this may have prevented the mix up.The male luer is compatible with the extension sets that are used with the regular iv tubing sets) and when they went to connect it to the bupivacaine it was found that the bupivacaine had been connected to her peripheral iv on the left arm.Patient was mildly lethargic, tachycardic at 110 bpm, alert and oriented x3.A suspected local anesthetic systemic toxicity (last) protocol was initiated.Ekg showed st with no av/sa nodal block.A 20% intralipid infusion was bolused, followed by a continous infusion.The patient was transferred to icu for closer monitoring.The patient was transferred back to floor status the following day without any harm noted.
 
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Brand Name
CADD YELLOW-STRIPED ADMINISTRATION SET
Type of Device
INFRACLAVICULAR NERVE BLOCK CATHETER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
MDR Report Key5815053
MDR Text Key50188144
Report Number5815053
Device Sequence Number1
Product Code BSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date03/31/2021
Device Catalogue Number21-7339-24
Device Lot Number2021-03 46X196
Other Device ID NumberGTIN:(01)10610586027307
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/22/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer06/22/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
PATIENT HAD A PERIPHERAL IV 22G IN LEFT ARM AND AN
Patient Age25 YR
Patient Weight78
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