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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL PE INFANT WET LF 6/CS; BOTTLE, COLLECTION, VACUUM

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TELEFLEX MEDICAL PE INFANT WET LF 6/CS; BOTTLE, COLLECTION, VACUUM Back to Search Results
Catalog Number A-6020-08LF
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that there was a break at the connector.The report states that "the baby was in the winnie palmer nicu, the staff stated that the provider disconnected the pleura vac to reposition the chest tube, once the chest tube was in the correct position, the provider attempted to reconnect the pleura vac and the connection piece broke off inside of the chest tube line.Provider subsequently had to pull out the chest tube and put a new one in.The baby is still in the nicu with a chest tube in place".
 
Manufacturer Narrative
Qn#(b)(4).Customer complaint cannot be confirmed as a manufacturing defect, although provided sample shown a damage at the connector, there is not enough evidence that shows that the damage was caused during the manufacturing process since damage could occurred during transportation or handling of the unit to end user.The device history record has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.However, complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that there was a break at the connector.The report states that "the baby was in the winnie palmer nicu, the staff stated that the provider disconnected the pleura vac to reposition the chest tube, once the chest tube was in the correct position, the provider attempted to reconnect the pleura vac and the connection piece broke off inside of the chest tube line.Provider subsequently had to pull out the chest tube and put a new one in.The baby is still in the nicu with a chest tube in place".
 
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Brand Name
PE INFANT 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
mariah mackinnon
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18101803
MDR Text Key327733276
Report Number3004365956-2023-00073
Device Sequence Number1
Product Code KDQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/24/2023
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 Catalogue NumberA-6020-08LF
Device Lot Number74J2200446
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2023
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/24/2023
Initial Date FDA Received11/09/2023
Supplement Dates Manufacturer Received12/15/2023
Supplement Dates FDA Received12/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
N/A.
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