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

Model Number IPN028442

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is not available for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Drain was fitted in icu to replace initial drain fitted in theatres as hospital staff believe the drain fitted was faulty.This drain has also presented a constant rapid bubbling in the air leak meter.Staff troubleshooted by clamping tubing connected to the patient and bubbling continued then clamped the corrugated tubing below the red sample port and the bubbling ceased.Site believe the red sample port to be where the leak is occurring.A 3rd new drain has now been fitted to this patient.Patient was not harmed.As this drain has 10ml of blood it cannot be collected and sent for further investigation.

Manufacturer Narrative

(b)(4).The device history record of batch number 74m2000600 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 & inspected according to our specifications.Manufacture date:2020-12-10.Expiration date:2023-12-09.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility neither is being manufactured at the time.If defective sample becomes available at a later date this complaint will be updated as applicable.

Event Description

Drain was fitted in icu to replace initial drain fitted in theatres as hospital staff believe the drain fitted was faulty.This drain has also presented a constant rapid bubbling in the air leak meter.Staff troubleshooted by clamping tubing connected to the patient and bubbling continued then clamped the corrugated tubing below the red sample port and the bubbling ceased.Site believe the red sample port to be where the leak is occurring.A 3rd new drain has now been fitted to this patient.Patient was not harmed.As this drain has 10ml of blood it cannot be collected and sent for further investigation.

• Brand Name: PE ADULT-PED DRY/ WET LF
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12315514
• MDR Text Key: 266300558
• Report Number: 3004365956-2021-00266
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• Combination Product (y/n): N
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2023
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74M2000600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1