MAUDE Adverse Event Report: COVIDIEN SINGLE LUMEN INSERTION TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	43309
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reports after insertion, the picc broke while the dressing was being changed.There was no harm to the patient.
Additional Manufacturer Narrative
A device history review (dhr) revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.One used sample was received inside a plastic bag for analysis and investigation.Visual inspection was performed on the sample.The sample shows signs of use (residues of blood).The catheter was split in two parts and an irregular cut can be shown where the split occurs.Manufacturing performs 100% leak test; therefore a leakage/cracked would be detected during these processes.It is important to consider that the instructions for use state: do not use a sharp clamp or instrument to handle the catheter since even a minor cut could tear or break the catheter.Do not stretch catheter.Too much tension could tear the catheter.Do not use alcohol or acetone based skin preparations, adhesive enhancers, or solutions directly on the catheter.Based on the available information the most probable root cause is that the device was damaged during use.The reported complaint has not been confirmed as a manufacturing related issue.No trends or triggers have been found.Therefore, a corrective or preventive action is not deemed necessary at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: SINGLE LUMEN INSERTION TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 8620835
• Report Number: 3009211636-2019-00657
• Device Sequence Number: 19342645
• Product Code: LJS
• UDI-Device Identifier: 10884527004676
• UDI-Public: 10884527004676
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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: No Information
• Device Model Number: 43309
• Device Catalogue Number: 43309
• Device Lot Number: 1815600122
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 08/29/2019
• Patient Sequence Number: 1