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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the picc line was in from (b)(6) 2020 - (b)(6)2020.There was a hub change the night before at 10:00 pm (monday, april 27).During the dressing change, they noticed a loose steri-strip.On tuesday at 1:00 pm, the picc team noticed that there was a leak on the picc.The patient had to get a mid-line.There was no patient injury.
Additional Manufacturer Narrative
Additional information was received from the customer on 28-may-2020.
Event or Problem Description
The customer reported that the picc line was in from (b)(6) 2020 - (b)(6) 2020.There was a hub change the night before at 10:00 pm (monday, (b)(6)).During the dressing change, they noticed a loose steri-strip.On tuesday at 1:00 pm, the picc team noticed that there was a leak on the picc.The patient had to get a mid-line.There was no patient injury.Additional information was received from the customer that stated that the issue occurred just above the butterfly where the extension tubing meets the butterfly.The hub was changed on (b)(6) 2020.Leaking was discovered on (b)(6) 2020.They noted that during the dressing change the orientee used a chg wipe to hold the line instead of a 4x4 gauze.Chlorapep was used to clean the area.The area was completely dried prior to insertion.There was no difficulty in handling the catheter during insertion and it went right in.It was difficult to secure the insertion site because the patient was sweaty.The clamp that comes with the catheter was used.The device was inserted on the right basilic vein in the arm.It was continuous use but with antibiotics periodically.10ml syringe with normal saline was used to flush lines.Prevantics was used to clean the device at the hub connector, chg/alcohol mix, (3.1% chorahexadine/gluconate) did not clean the tubing.The device was removed on (b)(6) 2020 and replaced with a midline.There was no follow up care needed.

• 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: 10051520
• Report Number: 3009211636-2020-00697
• Device Sequence Number: 3513886
• Product Code: LJS
• UDI-Device Identifier: 10884527004676
• UDI-Public: 10884527004676
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/28/2020

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
• Operator of Device: No Information
• Device Model Number: 43309
• Device Catalogue Number: 43309
• Device Lot Number: 1927600154
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 05/28/2020
• Patient Sequence Number: 1
• Patient Age: 44 WK
• Patient Weight: 4