MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Catalog Number HS-05501

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the corners of the trays are cracking, creating a potential sterility issue.One tray was discovered after opening for a procedure and subsequent inventory was checked.

Event Description

It was reported that the corners of the trays are cracking, creating a potential sterility issue.One tray was discovered after opening for a procedure and subsequent inventory was checked.

Manufacturer Narrative

(b)(4).A device history record review was performed on the outer tray and kit with a potential relevant finding.Per (b)(4), during incoming inspection for outer tray t-05600-100b (lot#23p19a0261), a white powder residue observed on some of the trays.A rework was performed to remove the residue and the trays were re-inspected and accepted.This is not relevant to this complaint.The customer reported the outer tray of the kit cracking potentially causing sterility issues.The customer returned one sealed kit (reference attached files (b)(4)).Visual examination of the returned kit revealed the upper left and right corners show signs of stress.Also, the upper left corner is cracked under the flange.No other defects or anomalies were observed.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.Per the manufacturing site, all incoming outer trays are visually inspected for evidence of stress marks prior to packaging as well as each packaged kit is inspected after sealing and prior to being placed into the corrugate container.Also, packaging and engineering personnel attempted to duplicate opening sealed kits but concluded significate manual force is needed to crack one or more of the corner of the kit.The reported complaint of the tray is cracking was confirmed based on the sample received.Visual inspection of the returned kit revealed the upper left and right corners showed signs of stress as well as the lower left corner having crack under the flange.A device history record review was performed on the outer tray and kit with no relevant findings.Also, the outer trays are 100% inspected prior to and after packaging.It is unknown how the kit was handled during shipping or prior to use.The investigation found no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the trays corners being stressed and cracking could not be determined.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8519497
• MDR Text Key: 142110840
• Report Number: 1036844-2019-00434
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

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: 04/30/2020
• Device Catalogue Number: HS-05501
• Device Lot Number: 23F19A0471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1