MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS JELCO SAFETY PROTECTIV CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 306601

Device Problem Material Fragmentation (1261)

Patient Problem Blood Loss (2597)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

Ten unused samples were returned for investigation. Visual inspections of the devices found them to be in good physical condition, with no nonconformances. Based on sample evaluation, the complaint cannot be confirmed as a manufacturing nonconformance. In order to assure that our products meet functional requirements, the dimensions of the catheter components (eyelet, tubing, and hub) are tightly controlled. During the manufacturing process, smiths catheters are tested to assure that the tubing will not tear, break or otherwise fail. During the manufacture, critical parameters are 100 percent controlled during the different phases. Once the catheters are assembled, the tube, eyelet, and hub are inspected to demonstrate that the catheter tube is properly secured to the hub. The reported customer complaint has not been confirmed.

Event Description

Information was received that while a smiths medical catheter was in use, patient noticed blood pooling at iv site, and it was subsequently removed. However, it was reported that while attempting to do so, the cannula di not withdraw from the patient's vein. Alcohol was used to determine if cannula could be seen. Pressure was given to the arm and a tourniquet applied to site; nailbed capillary was monitored. Patient was taken to surgery for removal of detached cannula. It was also reported that no foreign body could be seen on ct or film. The surgery was unsuccessful however. No further adverse effects reported.

• Brand Name: SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS JELCO SAFETY PROTECTIV
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9088756
• MDR Text Key: 159391101
• Report Number: 3012307300-2019-05018
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 306601
• Device Lot Number: 3832371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 09/19/2019 Patient Sequence Number: 1