MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC

Model Number IPN050122

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during the insertion of the catheter by the surgeon in the resuscitation pediatric department, the guide pierced the catheter.Clinical consequences: pain plus bleeding for the child.Additional information: there were no clinical consequences, the patient is fine.No medical intervention was required.The device is not available, it was discarded.

Event Description

It was reported that during the insertion of the catheter by the surgeon in the rescucitation pediatric department, the guide pierced the catheter.Clinical consequences: pain plus bleeding for the child.Additional information: there were no clinical consequences, the patient is fine.No medical intervention was required.The device is not available, it was discarded.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.No sample was returned for investigation; therefore, no physical investigation could be conducted.Protruded stylet wire most likely to occur when it was not inserted correctly, or during re-insertion.Due to no actual sample returned for this complaint, further investigation was not possible.Therefore, this complaint could not be confirmed.

• Brand Name: BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10643500
• MDR Text Key: 211435702
• Report Number: 8040412-2020-00212
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

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 Model Number: IPN050122
• Device Catalogue Number: 170003-000060
• Device Lot Number: 20BG37
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1