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

Catalog Number A-7000-08LF

Device Problems Leak/Splash (1354); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

It was reported that "customer claiming item leaked/dispensed wrong amount of fluid internally." injury was indicated in the initial information provided by the complainant; however multiple attempts have been requested to the complainant with no response.Unknown at the time of report patient health status.

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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Manufacturer Narrative

Qn#(b)(4).The report that the 'leaked/dispensed wrong fluid internally' could not be confirmed, based only on the information provided, as no sample was returned for analysis.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 neither is being manufactured at the time.The device history record of batch number 74e2201572 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled & inspected according to our specifications.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that "customer claiming item leaked/dispensed wrong amount of fluid internally." injury was indicated in the initial information provided by the complainant; however multiple attempts have been requested to the complainant with no response.Unknown at the time of report patient health status.

• Brand Name: ARROW PE ADULT-PED 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17148444
• MDR Text Key: 317688029
• Report Number: 3004365956-2023-00040
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A-7000-08LF
• Device Lot Number: 74E2201572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.