MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAFETY PROTECTIV PLUS CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

Model Number 306601

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

One jelco safety protective plus catheter was returned for analysis without the severed tube segment, needle guard assembly, sheath, or blister packaging.The sample was examined under magnification and photographed.The eyelet to tube securement area within the catheter hub was intact with no evidence of catheter securement issues.Examination of the catheter assembly noted that the catheter tube was severed at 1/16" above the catheter hub nose.Examination of the catheter hub displayed evidence of damage to the catheter hub nose.The manufacturing process was reviewed; an issue with low puck count in the pcm2 bevel module on a shift in may with no cause established.An attempt to replicate the damage found in the faulted sample was performed to another sample.It too was examined under magnification and photographed finding similarity to the complaint sample.The replicate sample also displayed evidence of a puncture in the catheter tubing, but the shape of the damage to the catheter tube differs from the complaint sample.Based on the evidence, the complaint was confirmed.The root cause was found due to manufacturing.

Event Description

Information was received indicating that upon removal of a smiths medical jelco safety protective plus catheter, the catheter broke off at the hub, leaving the tip in the cephalic vein.Vascular surgery was reported to remove the fragment in the operating room.There were no further reported adverse effects.

• Brand Name: JELCO SAFETY PROTECTIV PLUS CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10532245
• MDR Text Key: 206919800
• Report Number: 3012307300-2020-09282
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071170
• UDI-Public: 10351688071170
• 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,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/05/2023
• Device Model Number: 306601
• Device Catalogue Number: 306601
• Device Lot Number: 3981802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 125