MAUDE Adverse Event Report: TELEFLEX MEDICAL EPIDURAL CATHETERIZATION KITEPIDURAL CATHETERI; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN919630
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	02/14/2022
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
Two catheters broke apart and 4.3cm remains in the patients back.Additional information: it happened with different patients around the same time.
Additional Manufacturer Narrative
Qn#(b)(4).The customer reported the catheter separated during use.The customer returned one snaplock assembly and two epidural catheter pieces.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter pieces revealed on the likely most proximal piece, the extrusion and coil wire are slightly stretched at the likely distal end.The extrusion and coil wire on the likely most distal piece are also stretched at the point of separation at the likely proximal end.Also, both the proximal and distal ends of the returned catheter pieces appear to be intact.The catheter appears to have been used as biological material can be seen on the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the catheter using a ruler (10171599).The proximal end catheter extrusion piece measures approximately 55.9cm.The distal end catheter piece measures approximately 36.5cm.Both catheter pieces combine to measure approxim ately 92.4cm.None of the catheter appears to be missing.However, with the coils and extrusion being stretched, this is why the catheter is just outside of the specification of 88.5-91.5 cm per graphic kz-05400-030 rev.5 and kz-05400-002 rev.10.Specifications per graphic kz-05400-030 rev.5 and kz-05400-002 rev 10 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109b rev.2, was reviewed as a part of this complaint investigation.The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal.".A corrective action is not required at this time as the condition of the sample received indicates unintentional user error caused or contributed to this event.The reported complaint of epidural catheter separated during use was confirmed based upon the sample received.The customer returned two catheter pieces that were separated at the extrusion.None of the catheter was missing.At the point of separation, the extrusion and coil wire are slightly stretched on the likely proximal piece and is also stretched on the likely distal piece.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.Therefore, based upon the condition of the sample received, unintentional user error caused or contributed to this event.No further action is required at this time.
Event or Problem Description
Two catheters broke apart and 4.3cm remains in the patients back.Additional information: it happened with different patients around the same time.
Additional Manufacturer Narrative
(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter 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 lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.Therefore, 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.
Event or Problem Description
Two catheters broke apart and 4.3cm remains in the patients back.Additional information: it happened with different patients around the same time.

• Brand Name: EPIDURAL CATHETERIZATION KITEPIDURAL CATHETERI
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; 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: 13693330
• Report Number: 1036844-2022-00014
• Device Sequence Number: 17466680
• Product Code: BSO
• UDI-Device Identifier: 10801902189315
• UDI-Public: 10801902189315
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 02/16/2022

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 Model Number: IPN919630
• Device Catalogue Number: SJ-05501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 04/04/2022; 04/26/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/06/2022; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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