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

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.

• Brand Name: FLEXTIP PLUS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 2400 bernville road; reading PA 19605
• MDR Report Key: 5013152
• MDR Text Key: 23401134
• Report Number: 5013152
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Date: 06/01/2016
• Device Lot Number: 23F15A2004
• Other Device ID Number: 020815
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• 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 Number: 1
• Patient Age: 28 YR
• Patient Weight: 78