MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK EFX SHIELD PORT SITE CLOSURE SYSTEM; INSTRUMENT, LIGATURE PASSING A

Model Number	IPN914218
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The plastic "v" at the bottom pf the device became detached while inside of patient.Additional information: yes, it did fall inside the patient but was retrieved at the time without incident.
Additional Manufacturer Narrative
(b)(4).Device was not available for return.A batch record review for referenced lot #3352500000 was performed and it did not indicate any atypical issues during production and no ncrs were noted.All units undergo 100 % mechanical tensile testing and visual inspection to wings for cracks and breaks per our mel-100232 for test acceptance criteria developed and provided by teleflex.Units that fail are scrapped and passing units are accepted.Whereas there was no device available for return our mel-100232 for test acceptance criteria developed and provided by teleflex.Units that fail test are scrapped and passing units are accepted.Whereas there was no device available for return evaluation, this complaint is deemed neither verified or valid and cannot be confirmed.
Event or Problem Description
The plastic "v" at the bottom pf the device became detached while inside of patient.Additional information: yes, it did fall inside the patient but was retrieved at the time without incident.

• Brand Name: WECK EFX SHIELD PORT SITE CLOSURE SYSTEM
• Common Device Name: INSTRUMENT, LIGATURE PASSING A
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12049557
• Report Number: 3011137372-2021-00164
• Device Sequence Number: 19940642
• Product Code: HCF
• UDI-Device Identifier: 14026704645272
• UDI-Public: 14026704645272
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 10/19/2023
• Device Model Number: IPN914218
• Device Catalogue Number: EFX002
• Device Lot Number: 3352500000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.