MAUDE Adverse Event Report: TELEFLEX MEDICAL PE ADULT-PED WET LF 6/CS; BOTTLE, COLLECTION, VACUUM

Model Number IPN028449

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Pneumothorax (2012)

Event Date 03/08/2023

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).Two photographs of catalog number a-8000-08lf pe adult-ped wet lf 6/cs were received for analysis.In the first photograph it can observed a pleur-evac bottle with a damage in the port where the patient tube is connecting.In the second photograph shows the label back lbl024291 r01.A functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record of batch number 74h2200125 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.The customer complaint cannot be confirmed as a manufacturing defect, although provided photographs shown a damage at the patient port, there is not enough evidence that shows that the damage was caused during the manufacturing process since damage could occurred during transportation or handling of the unit to end user.However, complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.

Event Description

Reported issue: it was reported that there was a rupture in the drainage tube where air entered.This resulted in the ingress of air in the drainage resulting in pneumothorax and subcutaneous emphysema, detected through x-ray performed the day after.The pleurevac was promptly replaced with no consequences for the patient, other than maintaining the drainage for an additional day and a consequent increase in hospitalization.

Manufacturer Narrative

(b)(4).The device was returned and sent to the manufacturing site for investigation.The manufacturing site reports "one unit of catalog number a-8000-08lf (pe adult-ped wet lf 6/cs) was received for analysis.Sample wasn't received in its original packaging.In the visual inspection it was observed the patient tube disconnected and the a damage on patient port.No other issues were observed." the device history record of batch number 74h2200125 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Although damage at the patient port was observed, the issue could not be confirmed as a manufacturing defect.A root cause could not be identified.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Reported issue: it was reported that there was a rupture in the drainage tube where air entered.This resulted in the ingress of air in the drainage resulting in pneumothorax and subcutaneous emphysema, detected through x-ray performed the day after.The pleurevac was promptly replaced with no consequences for the patient, other than maintaining the drainage for an additional day and a consequent increase in hospitalization.

• Brand Name: PE ADULT-PED WET LF 6/CS
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16623253
• MDR Text Key: 312099430
• Report Number: 3004365956-2023-00025
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 34026704631309
• UDI-Public: 34026704631309
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028449
• Device Catalogue Number: A-8000-08LF
• Device Lot Number: 74H2200125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Hospitalization; Required Intervention