MAUDE Adverse Event Report: TELEFLEX MEDICAL PLEUR-EVAC CHEST DRAINAGE SYSTEM; BOTTLE, COLLECTION, VACUUM

Catalog Number	S-1100-08LF
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
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
Reported issue: we recently have been noticing air leaks in the connection of our pleur-evac.This becomes misleading in the assessment of the patient as bubbling occurs in the system and the nurses need to do additional investigations to see the cause (pt vs equipment).In the attached photo the leak has been fixed with pink tape.This must be affecting the operating room as well as a good amount of our patient with these pleur-evacs come from operating room.
Additional Manufacturer Narrative
(b)(4).A dhr review could not be conducted since involved lot number was not provided.Even though complete sample was provided from the customer it was not possible to cross it to nuevo laredo facility due to contamination on it therefore just ats connectors were received for investigation at nuevo laredo.No damage was found on section of received sample that can lead to a leaking issue.Functional inspection test cannot be performed since the sample involved in this customer complaint was receive incomplete only the ats connectors were received for evaluation.Section of sample received was connected and adapted to a source of air (tfm-0060 nlc09684 due date 22-mar-21) and then was submerged into the water and no leak were observed.Customer complaint cannot be confirmed based on functional inspection.No air leak was observed on ats connector received.
Event or Problem Description
Reported issue: we recently have been noticing air leaks in the connection of our pleur-evac.This becomes misleading in the assessment of the patient as bubbling occurs in the system and the nurses need to do additional investigations to see the cause (pt vs equipment).In the attached photo the leak has been fixed with pink tape.This must be affecting the or as well as a good amount of our patient with these pleur-evacs come from or.
Additional Manufacturer Narrative
Qn# (b)(4).A dhr review could not be conducted since involved lot number was not provided.A picture of catalog number s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) was received for analysis.During the visual inspection on the received picture a tape that is covering the ats connectors was observed, however it was not possible to confirm a leaking issue on the product as it is described on this customer complaint.Sample need to be evaluated in order to perform a proper investigation.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.If the sample becomes available this investigation will be updated with the evaluation results.
Event or Problem Description
Reported issue: we recently have been noticing air leaks in the connection of our pleur-evac.This becomes misleading in the assessment of the patient as bubbling occurs in the system and the nurses need to do additional investigations to see the cause (pt vs equipment).In the attached photo the leak has been fixed with pink tape.This must be affecting the or as well as a good amount of our patient with these pleur-evacs come from or.

• Brand Name: PLEUR-EVAC CHEST DRAINAGE SYSTEM
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10986782
• Report Number: 3004365956-2020-00264
• Device Sequence Number: 19643483
• Product Code: KDQ
• UDI-Device Identifier: 44026704428906
• UDI-Public: 44026704428906
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2020

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 Catalogue Number: S-1100-08LF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 12/07/2020; 02/17/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/07/2021; 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1