MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA X 35; CATHETER, CONDUCTION, ANESTHET

Catalog Number ASK-05503-BWB

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: customer noted they have had some issues with the luer lock glass syringes related to product quality.The threads on a few have been bent making it difficult/impossible to screw on to the tuohy needle.They have also had issues with leakage at the connection point, also consistent with the threads not lining up.

Event Description

Reported issue: customer noted they have had some issues with the luer lock glass syringes related to product quality.The threads on a few have been bent making it difficult/impossible to screw on to the tuohy needle.They have also had issues with leakage at the connection point, also consistent with the threads not lining up.

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 lor syringe with no relevant findings.The customer reported issues connecting the lor syringe to the epidural needle causing a leak at the connection.The customer returned one 5ml glass syringe.The returned lor syringe was visually examined with and without magnification.Visual examination of the syringe revealed on the metal tip, the male center of the tip is bent.No other visual defects or anomalies were observed.Functional inspection was performed on the returned lor syringe.An attempt to connect the lor syringe to a lab inventory epidural needle was performed.However, based on the condition of the returned lor syringe, a clean secure connection could not be achieved.A nonconformance has been initiated to further investigate this complaint issue.The reported complaint of issues connecting the lor syringe to the epidural needle was confirmed based on the sample received.Visual examination of the returned lor syringe revealed the male center of the metal tip was bent causing the syringe to not make a clean secure luer connection to female luer components.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 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 KIT: 19 GA X 35
• Type of Device: CATHETER, CONDUCTION, ANESTHET
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10792433
• MDR Text Key: 214788864
• Report Number: 1036844-2020-00283
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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 Catalogue Number: ASK-05503-BWB
• Device Lot Number: UNAVAILABL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1