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

Catalog Number 306001

Device Problems Material Fragmentation (1261); Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

Foreign report source: (b)(6).

Event Description

Information was received that a smiths medical jelco protectiv safety i.V.Catheter severed while in use.The issue was discovered when attempting to flush the iv and fluid was reported to be leaking around the site.After the patient's iv was discontinued, it was reported cannula was not attached to the blue hub.Subsequently, the retained iv catheter was identified on an x-ray of the wrist and the patient required surgery to have the product removed.Patient was reported to be "doing well." no additional adverse patient effects were reported.

Manufacturer Narrative

One device returned for evaluation.Magnification of the device confirms the catheter tube to be detached and severed at the catheter hub nose area.No evidence of bevel tip irregularities.The distal end of the tube / point of detachment is straight and smooth.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

Manufacturer Narrative

One cuffed blue line suctionaid was returned for analysis in used condition.No discrepancies were noted upon visual examination.Leak test was performed by inflating the cuff while submerged under water; leak was observed coming from the cuff.Relevant documents and manufacturing process were reviewed and deemed adequate.The cuff assembly operation and the inflation line assembly operation were reviewed; no discrepancies were found.Inflation test was audited during thirty two (32) units with no deflated cuffs were detected.Based on the evidence the complaint was confirmed.However, the root cause is unknown.

• Brand Name: JELCO PROTECTIV SAFETY I.V. CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8087479
• MDR Text Key: 127847628
• Report Number: 3012307300-2018-08244
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071187
• UDI-Public: 10351688071187
• Combination Product (y/n): N
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/05/2021
• Device Catalogue Number: 306001
• Device Lot Number: 3578450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention