MAUDE Adverse Event Report: TELEFLEX MEDICAL PE ADULT-PED DRY/ WET LF 6/CS; BOTTLE, COLLECTION, VACUUM

Model Number IPN028442

Device Problem Defective Component (2292)

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

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One unit of catalog number a-6000-08lf (pe adult-ped dry/ wet lf 6/cs) lot 74h2000608 was received for analysis.Sample was not received in its original packaging.It was noticed that a corner was broken.No other issues were observed.A dimensional inspection was not performed as part of this complaint investigation.The suction port was connected to a suction source at 60 cm h2o.The unit was set to all set points (-10, -15, -20, -30 and -40cm of water and no issues were observed, the orange float appears in the indicator window for each set point.The device history record of batch number 74h2000608 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 and inspected according to our specifications.Ifu says "increase source suction until the orange float appears in the suction indicator window".No corrective action can be established since no problem found on sample.The customer complaint cannot be confirmed since no problem found on sample during functional inspection.The orange float was observed in all set points.Also, the sample shows a broken corner, however, it cannot be confirmed that such damage was caused during the manufacturing process since damage could occurred during transportation or handling of the unit to end user.

Event Description

It was reported that the floater was not showing when attached to suction.The device was being used for a coronary bypass and a new unit was used.

Event Description

It was reported that the floater was not showing when attached to suction.The device was being used for a coronary bypass and a new unit was used.

Manufacturer Narrative

(b)(4).One unit of catalog number a-6000-08lf (pe adult-ped dry/ wet lf 6/cs) lot 74h2000608 was received for analysis.Sample wasn't received in its original packaging.It was noticed a corner broken.No other issues were observed.Suction port was connected to a suction source at 60 cm h2o.The unit was set to all set points (-10, -15, -20, -30 and -40cm of water and no issues were observed, the orange float appears in the indicator window for each set point.The device history record of batch number 74h2000608 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.Ifu says "increase source suction until the orange float appears in the suction indicator window" no corrective action can be established since no problem found on sample.Customer complaint cannot be confirmed since no problem found on sample during functional inspection.The orange float was observed in all set points.Also, sample shown a broken corner, however, it cannot confirmed that such damage was caused during the manufacturing process since damage could occurred during transportation or handling of the unit to end user.

• Brand Name: PE ADULT-PED DRY/ WET LF 6/CS
• Type of Device: 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15814487
• MDR Text Key: 307188562
• Report Number: 3004365956-2022-00085
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2023
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74H2000608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Age: 74 YR
• Patient Sex: Male