MAUDE Adverse Event Report: SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN045611
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
We are writing this email to inform you of a manufacturing defect that we encountered in one of the teleflex arrow flextip plus combined spinal - epidural kits.The lumen of the epidural lumen was blocked by a piece of plastic.We reviewed the literature and recognized that this complication has never been seen before.We are writing it as a case report to be published in the international journal of obstetric anesthesia.We have attached images of the blocked epidural lumen with this email for you to see.The device was being used on a patient.The patient was stable and was presenting in labor for spontaneous vaginal delivery.The medical intervention required was we needed to redo the epidural with a different kit from a different lot number as we could not thread the catheter through this needle.The kit was discarded after we took pictures of the lumen (for publishing purposes).
Event or Problem Description
We are writing this email to inform you of a manufacturing defect that we encountered in one of the teleflex arrow flextip plus combined spinal - epidural kits.The lumen of the epidural lumen was blocked by a piece of plastic.We reviewed the literature and recognized that this complication has never been seen before.We are writing it as a case report to be published in the international journal of obstetric anesthesia.We have attached images of the blocked epidural lumen with this email for you to see.The device was being used on a patient.The patient was stable and was presenting in labor for spontaneous vaginal delivery.The medical intervention required was we needed to redo the epidural with a different kit from a different lot number as we could not thread the catheter through this needle.The kit was discarded after we took pictures of the lumen (for publishing purposes).
Additional Manufacturer Narrative
Qn#: (b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.Visual inspection could not be performed as no sample was returned by the customer for investigation.The customer did provide photos that displays a needle from the top of the hub which appears to show something inside the cannula (reference files pic1-tc# (b)(4)).A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter and needle with no evidence to indicate a manufacturing related issue.The customer did provide photos that appear to show something inside the epidural needle's cannula.However, without the actual sample, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.

• Brand Name: SPINAL ANES/EPIDURAL CATH KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• MDR Report Key: 12232383
• Report Number: 1036844-2021-00144
• Device Sequence Number: 19753312
• Product Code: BSO
• UDI-Device Identifier: 10801902005172
• UDI-Public: 10801902005172
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: IPN045611
• Device Catalogue Number: AK-05560
• Device Lot Number: 23F21B0169
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.