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 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number 74d2001308 that belong to catalog number a-6000-08lf pe adult-ped dry/ wet lf has been reviewed and no issues or discrepancies were found which could potentially be related 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 device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Involved a (b)(6)-year-old female patient, hospitalized in the thoracic surgery department for postoperative monitoring of an upper left lobectomy complicated by haemorrhagic shock.The users notice a suction failure of the pleur-evac drainage system: presence an air leak at the connection between the patient drain and pleur-evac tubing ats red-blue connector.Clinical consequences: there was a delay of the pulmonary re-expansion.The patient was discharged from the hospital on (b)(6) 2021 following a left upper lobectomy performed on (b)(6) 2021.The discharge letter does not mention any negative consequences to the patient's health status attributed to the incident.

Manufacturer Narrative

Qn#(b)(4).A visual inspection of the product involved in the complaint was performed on a representative sample of product code a-6000-08lf (pe adult-ped dry/ wet lf) received under customer complaints (b)(4).And while performing the visual inspection test it was confirmed that the tubing is assembled correctly on each end of the ats connectors.The assembly of the ats connectors was verified and no issues were observed that can lead to a leaking issue.Ats connectors were disconnected in order to verify the assembly of the o-ring and it was found assembled correctly.Received sample was filled with water and no leakage at the ats connectors were found.Received sample was connected to simulate the use using water; it was tested with suction and no leakage issues were observed, the sample was connected and disconnected several times to see if any of these disconnections could lead to a leakage issue and no leaks were observed.A visual inspection of the product involved in the complaint was performed on a representative sample of product code a-6000-08lf (pe adult-ped dry/ wet lf) received under customer complaints (b)(4).And while performing the visual inspection test it was confirmed that the tubing is assembled correctly on each end of the ats connectors.The assembly of the ats connectors was verified and no issues were observed that can lead to a leaking issue.Ats connectors were disconnected in order to verify the assembly of the o-ring and it was found assembled correctly.(see attached pictures) received sample was connected to simulate the use using water; it was tested with suction and no leakage issues were observed, the sample was connected and disconnected several times to see if any of these disconnections could lead to a leakage issue and no leaks were observed; based on sample received and inspection (visual and dimensional) & testing perform to it; customer complaint cannot be confirmed; nuevo laredo facility will continue to track and trend this failure mode.Based on previous statements it is not possible to establish corrective actions.

Event Description

Involved a 72-year-old female patient, hospitalized in the thoracic surgery department for postoperative monitoring of an upper left lobectomy complicated by haemorrhagic shock.The users notice a suction failure of the pleur-evac drainage system: presence an air leak at the connection between the patient drain and pleur-evac tubing ats red-blue connector.Clinical consequences: there was a delay of the pulmonary re-expansion.The patient was discharged from the hospital on (b)(6) 2021 following a left upper lobectomy performed on (b)(6) 2021.The discharge letter does not mention any negative consequences to the patient's health status attributed to the incident.

• Brand Name: PE ADULT-PED DRY/ WET LF
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11665452
• MDR Text Key: 245390270
• Report Number: 3004365956-2021-00129
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74D2001308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1