MAUDE Adverse Event Report: TELEFLEX MEDICAL PE SAHARA DRY SUCT/DRY SEAL LF 6/CS; 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	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual inspection test was performed on a picture provide by the customer showing a label of product code s-1100-08lf however the device involved on this customer complaint is not on the received picture.The customer complaint cannot be confirmed since a picture of the device involved on this customer complaint was not provide.The device history record of batch number 74f2001464 that belong to catalog number s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) 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.The device history review shows that the product was assembled and inspected according to our specifications.The customer complaint cannot be confirmed since a picture of the device involved on this customer complaint was not 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 nor is being manufactured at the time.If the sample becomes available this investigation will be updated with the evaluation results.
Event or Problem Description
The event occurred tuesday evening (b)(6).There was no adverse event to the patient.There were 2 nurses troubleshooting the canister and found it to be leaking at the connection site between the blue and red port same as the others.

• Brand Name: PE SAHARA DRY SUCT/DRY SEAL LF 6/CS
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11045884
• Report Number: 3004365956-2020-00270
• Device Sequence Number: 11034586
• 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
• Report Date (Section B): 12/10/2020

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 Expiration Date: 05/15/2023
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74F2001464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1