MAUDE Adverse Event Report: NULL JELCO; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number 4033-AI

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2020

Event Type  malfunction  

Manufacturer Narrative

One smiths medical peripheral intravenous catheters (pivc)|jelco conventional jelco iv catheter was returned for analysis.The visual analysis confirmed that the catheter bevel was detached, and 4 mm of the bevel were detached.It was noted that it is improbable that such type of damage may have been originated during the manufacturing process, considering that critical parameters are 100 % controlled during the different manufacturing phases.Based on the evidence, the complaint was not confirmed, and the problem source of the reported event was noted to be user interface.

Event Description

Information was received indicating that on removal of a smiths medical peripheral intravenous catheters (pivc)|jelco conventional jelco iv catheter, the cannula was noted not to be full length.The baby was reviewed by the surgical team who could not locate the missing piece and felt it was very unlikely to cause harm to the infant.Ultrasound was also performed and reviewed by surgical team, surgeon indicated no concern.No further adverse effects were reported.

• Brand Name: JELCO
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section G): NULL
• MDR Report Key: 12476423
• MDR Text Key: 271579510
• Report Number: 3012307300-2021-09379
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4033-AI
• Device Lot Number: 3969088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Weight: 2