MAUDE Adverse Event Report: TELEFLEX MEDICAL PE SAHARA DRY SUCT/DRY SEAL LF 6/CS; BOTTLE, COLLECTION, VACUUM

Model Number IPN028484

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Dhr shows that the product was assembled and inspected according to our specifications.

Event Description

There was leaking at the red and blue connectors on the pleur-evac tubing of both s-1100-08lf.Lot' 74f2001464.It did not seem to be working properly after the leak.After 2 units, they found another one to put on the patient.It was later reported that they used another 2 s-1100-08lf chest drains lot'74f2001464, but these 2 were leaking also at the same site.They have a picture that was sent.Picture below was in bed 2, was dripping blood into the floor on arrival.That is why a towel is on the floor.The bottom picture had an audible air leak at the red and blue connectors.We tried pushing the connectors together, but the leak continued.

Manufacturer Narrative

(b)(4).A visual inspection of the product involved in the complaint was performed on ats connectors received from the customer under customer complaints (b)(4) of product code s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs).No damage was found on the received sample that can lead to a leaking issue.Also, it was confirmed that the tubing is assembled correctly on each end of the ats connectors.The assembly of the o-ring was verified, and it was found assembled correctly.Even though complete sample was provide 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.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.Received sample was connected to a bottle 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; for testing purpose intentionally, a poorly connection on the ats connection was performed (50% assembled) and not leakage issues were observed.A visual inspection of the product involved in the complaint was performed on ats connectors provided by the customer of product code s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs).No damage was found on the received sample that can lead to a leaking issue.Also, it was confirmed that the tubing is assembled correctly on each end of the ats connectors.The assembly of the o-ring was verified , and it was found assembled correctly.Received sample was connected to a bottle 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; for testing purpose intentionally, a poorly connection on the ats connection was performed (50% assembled) and not leakage issues were observed.Based on sample received and 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

There was leaking at the red and blue connectors on the pleur-evac tubing of both s-1100-08lf.Lot' 74f2001464.It did not seem to be working properly after the leak.After 2 units, they found another one to put on the patient.It was later reported that they used another 2 s-1100-08lf chest drains lot'74f2001464, but these 2 were leaking also at the same site.They have a picture that was sent.Picture below was in bed 2, was dripping blood into the floor on arrival.That is why a towel is on the floor.The bottom picture had an audible air leak at the red and blue connectors.We tried pushing the connectors together, but the leak continued.

• Brand Name: PE SAHARA DRY SUCT/DRY SEAL LF 6/CS
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11372184
• MDR Text Key: 234783150
• Report Number: 3004365956-2021-00051
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 34026704631668
• UDI-Public: 34026704631668
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2023
• Device Model Number: IPN028484
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74F2001464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2020
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1