MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC SNAPLOCK CATHETER/SYRINGE ADAPTER; ANESTHESIA CONDUCTION KIT

Model Number	IPN047800
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Writer noticed epidural catheter was disconnected while repositioning patient from side to side.Patient's dermatome levels were t5.Part of the catheter that is connected to patient writer locked with sterile syringe.Tape was intact over patient's back, no migration of catheter.Dr.Inserted new epidural catheter and patient was comfortable in a few minutes after insertion, fetal heart rate and baseline was the same, normal tracing.Maybe manufacturer should suggest placing tape over it and also what kind of tape should be applied.There is no warning (or suggestions from manufacturer) on the package that we need to use tape over these parts.
Event or Problem Description
Writer noticed epidural catheter was disconnected while repositioning patient from side to side.Patient's dermatome levels were t5.Part of the catheter that is connected to patient writer locked with sterile syringe.Tape was intact over patient's back, no migration of catheter.Dr inserted new epidural catheter and patient was comfortable in a few minutes after insertion, fetal heart rate and baseline was the same, normal tracing.Maybe manufacturer should suggest placing tape over it and also what kind of tape should be applied.There is no warning ( or suggestions from manufacturer ) on the package that we need to use tape over these parts.
Additional Manufacturer Narrative
(b)(4).A device history review could not be performed on the epidural catheter as according to the bill of material (bom) for reported kit as-05500-1, an epidural catheter is not packaged with the reported kit.A device history record review was performed on the snaplock assembly with no relevant findings.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history review could not be performed on the epidural catheter as according to the bill of material (bom) for reported kit ou-05500-nron, an epidural catheter is not packaged with the reported kit.A device history record review was performed on the snaplock assembly with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.

• Brand Name: SNAPLOCK CATHETER/SYRINGE ADAPTER
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13894305
• Report Number: 1036844-2022-00020
• Device Sequence Number: 1713257
• Product Code: CAZ
• UDI-Device Identifier: 10801902137460
• UDI-Public: 10801902137460
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: IPN047800
• Device Catalogue Number: AS-05500-1
• Device Lot Number: 13F20L0062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Female