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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. FLEXTIP PLUS; ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL, INC. FLEXTIP PLUS; ANESTHESIA CONDUCTION KIT Back to Search Results
Lot Number 23F15A2004
Device Problems Material Too Rigid or Stiff (1544); Malposition of Device (2616); Packaging Problem (3007)
Patient Problem Tingling (2171)
Event Date 06/03/2015
Event Type  malfunction  
Event Description
As reported by the certified registered nurse anesthetist (crna), when inserting the epidural catheter, the catheter went intra-thecal and the crna aspirated cerebrospinal fluid.The crna states this is the second wet tap the crna has had recently, and feels that the epidural catheter is stiffer than usual.Upon examining the catheter kits it was found that the packaging of the kits is different.The old kit has a clear plastic container and the new kit has blue non-see through container.The company was called and this was reported.The procedural note reads: "indications: labor analgesia as requested by patient and obstetrician.Complications: intrathecal catheter placement on first epidural placement.1st epidural placed l3-4, good lor at 4.5 cm depth, epidural space dilated with 2ml ns, catheter threaded easily.Clear fluid aspirated from epidural catheter.1 ml 1.5% lidocaine test administered.Some tingling in feet.Epidural removed and replaced at l2-3." the patient tolerated the l2-3 epidural well.The post-op anesthesia evaluation indicated the patient denied headache.
 
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Brand Name
FLEXTIP PLUS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL, INC.
2400 bernville road
reading PA 19605
MDR Report Key5013152
MDR Text Key23401134
Report Number5013152
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Report Date 07/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date06/01/2016
Device Lot Number23F15A2004
Other Device ID Number020815
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/28/2015
Event Location Hospital
Date Report to Manufacturer07/28/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/19/2015
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
Patient Age28 YR
Patient Weight78
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