MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CANNULA & CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PIK 100#INSERTION KIT, GUIDEWIRE 100 CM

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when further information becomes available.

Event Description

It was reported that small punture hole was observed during unpacking the product.Customer states that the sterility might be compromised.No harm to any person was reported.Complaint # (b)(4).

Manufacturer Narrative

It was reported that small punture hole was observed during unpacking the product.Customer states that the sterility might be compromised.No harm to any person was reported.The sample was investigated at maquet cardiopulmonary gmbh laboratory on 2023-11-01.The product was returned with a carton box however it was not the original carton of the product.Visual inspection was performed for the pik set sterile packaging.All seams were closed.A hole was detected at the paper side of the sterile bag, and kinks were detected at the paper side.Abrasion particles and fringes were observed around the hole.Based on the investigation results, failure could be confirmed however not product related.The production history record (dhr) of the affected pik 100#insertion kit, guidewire 100 cm with lot# 3000310455 was reviewed on 2023-10-10.According to the dhr result, the product pik 100#insertion kit, guidewire 100 cm passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Further, the incoming inspection reports of the affected component sterile bag / 04187#steriltüte 320 x 500 mm, #700004187 (batch # 3000258343) was reviewed on 2023-10-24.The sterile bag was checked visually for particles, puncture, pinhole, gap, tear, burn/meltdown, wrinkle, stain and smooth surface.All tests were passed as per specifications.The non-conformity record review has been performed for the reported product and failure.There could not be any record that could cause to the failure of sterile package.Based on the laboratory investigation results: - it is very unlikely that the puncture has its origin from the inside of the medical paper, since the blister¿s purpose is exactly to fixate all sharp and pointed components of the pik.- in the investigation, it was observed that the puncture hole was found in the area of the folding of the medical paper (to fit in the cardboard) therefore, it is more likely that the medical paper was damaged while opening the cardboard.According to the bop 9204195, v18 the related packaging steps were demonstrated: - the visual controls were performed for the sterile package at the outer package area.- the folding direction of the sterile bag is clerified.The label is on the not folded side of the sterile bag.Besides, in the laboratory investigation it was clearly visible that the hole is in place on the not folded side of the package.Based on the investigation results, the most probable root cause have been found as: - user failure: damage to the sterile barrier (medical paper) while opening the cardboard.The root cause is not confirmed.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint #(b)(4).

• Brand Name: CANNULA & CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 17726978
• MDR Text Key: 323149018
• Report Number: 8010762-2023-00456
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K131666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIK 100#INSERTION KIT, GUIDEWIRE 100 CM
• Device Catalogue Number: 701047384
• Device Lot Number: 3000310455
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other