MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SETS; CATHETER, CONDUCTION, ANESTHE

Catalog Number ASK-05500-BCW

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Issue reported: the problem was that there was a leak in the glass lor syringe where the metal connects to the glass.There was no harm done.A second kit was opened to get a new syringe but that was all.

Event Description

Issue reported: the problem was that there was a leak in the glass lor syringe where the metal connects to the glass.There was no harm done.A second kit was opened to get a new syringe but that was all.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported the lor syringe was leaking where the metal tip connects to the glass syringe.The customer returned one glass lor syringe and lidstock.The returned syringe was visually examined with and without magnification.Visual examination of the syringe revealed the syringe is typical with no visual defects of anomalies observed.Functional testing was performed on the returned syringe using the lab leak tester ((b)(4)) per the parameters in amrq-000128 rev.3, section 7.3-positive pressure leakage.Water was aspirated into the syringe and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.A leak was detected where the metal tip connects to the glass syringe.A nonconformance have been initiated to further investigate this complaint issue.The reported complaint of the lor syringe leaking was confirmed based on the sample received.Visual examination of the returned sample did not reveal any defects or anomalies; however, functional testing revealed the lor syringe was found to be leaking where the metal tip connects to the glass syringe.A device history record review was performed on the lor syringe with no evidence to indicate a manufacturing related issue.The lor syringe is a purchased part.Therefore, the potential root cause of this issue is supplier related.A nonconformance has been initiated to further investigate this issue.

• Brand Name: EPIDURAL CATHETERIZATION SETS
• Type of Device: CATHETER, CONDUCTION, ANESTHE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10755254
• MDR Text Key: 213666884
• Report Number: 1036844-2020-00284
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: ASK-05500-BCW
• Device Lot Number: 13F20F0321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1