MAUDE Adverse Event Report: TELEFLEX MEDICAL A-6000-08LF; BOTTLE, COLLECTION, VACUUM

Model Number	IPN028442
Medical Device Problem Codes	Improper Flow or Infusion (2954); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Incident occurred on (b)(6) 2022 in the resuscitation department.The chest drain was inserted and then the pleur evac was connected, suction at 20 checked, orange indicator checked, liquid introduced for bubbling.Only about 200 ml of liquid were removed while the ultrasound performed showed a greater amount of fluid.The user connected a syringe directly to the drain and was able to aspirate approximately 300 ml.When the system was disconnected it did show suction but no fluid was collected.Between the use of each syringe, the user reconnected the pleur evac but he aspirated nothing.Another pleur evac was therefore placed and approximately 1100 ml were aspirated with this new device.There have been no other incidents reported.The users are experienced with the use of this device.Additional information: the patient did not suffer a pneumothorax.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Incident occurred on (b)(6) 2022 in the resuscitation department.The chest drain was inserted and then the pleur evac was connected, suction at 20 checked, orange indicator checked, liquid introduced for bubbling.Only about 200 ml of liquid were removed while the ultrasound performed showed a greater amount of fluid.The user connected a syringe directly to the drain and was able to aspirate approximately 300 ml.When the system was disconnected it did show suction but no fluid was collected.Between the use of each syringe, the user reconnected the pleur evac but he aspirated nothing.Another pleur evac was therefore placed and approximately 1100 ml were aspirated with this new device.There have been no other incidents reported.The users are experienced with the use of this device.Additional information: the patient did not suffer a pneumothorax.
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74k2001556 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: 2020-10-22.Expiration date: 2023-10-21.One unit of catalog number a-6000-08lf (pe adult-ped dry/ wet lf 6/cs) batch 74k2001556 was received for analysis.Sample wasn't received in its original packaging , and it can appreciate sing of use.One section of patient tube was not received.A section of patient tube was connected in sample to perform the functional test.Suction port was connected to a suction source at 60 cm h2o and patient tube was put in warm water (with blue dye).Suction was activated and collection chambers were filled with such water.No issues were observed, suction was performed correctly , and all chambers were filled.Sample was received incomplete.However, another section of patient tube was used to perform the functional test and no issues were observed.Suction was realized correctly.Therefore, no corrective actions are required.Customer complaint cannot be confirmed since sample was received incomplete and no functional issues were observed.Another section of patient tube was used to perform the functional test and no issues were observed.Suction was realized correctly.
Event or Problem Description
Incident occurred on (b)(6) 2022 in the resuscitation department.The chest drain was inserted and then the pleur evac was connected, suction at 20 checked, orange indicator checked, liquid introduced for bubbling.Only about 200 ml of liquid were removed while the ultrasound performed showed a greater amount of fluid.The user connected a syringe directly to the drain and was able to aspirate approximately 300 ml.When the system was disconnected it did show suction but no fluid was collected.Between the use of each syringe, the user reconnected the pleur evac but he aspirated nothing.Another pleur evac was therefore placed and approximately 1100 ml were aspirated with this new device.There have been no other incidents reported.The users are experienced with the use of this device.Additional information: the patient did not suffer a pneumothorax.

• Brand Name: A-6000-08LF
• Common Device Name: 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13620946
• Report Number: 3004365956-2022-00016
• Device Sequence Number: 11901082
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74K2001556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown