MAUDE Adverse Event Report: CAREFUSION SMALLBORE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number 20041E

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Hypoglycemia (1912)

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

Gtin/udi number for item 20041e, lot 16105691 is (b)(4).The customer¿s report of a set that cracked and leaked was confirmed.During inspection on both used sets received, it was noted that the female luer had a vertical hair line crack that measured 0.611 and 0.529 inches long.There were no other damages or any issues observed on the remainder of either set.The female luer was inspected under magnification to determine if any stress marks were noted; no stress marks were detected.Functional testing confirmed a leak as fluid flowed through the crack on the female luer on both used sets.The cause of the leak was a cracked female luer; however the root cause of the crack was not determined.

Event Description

Received a copy of the customer's medwatch report from fda, which states ¿when checking on patient, it was noticed that blood was backing up into the t-connector of a piv (peripheral intravenous line).The iv tubing was disconnected at the end of the t-connector to flush blood through, but the saline squirted out around the connection point.A new t-connector was placed at the end of the iv catheter & tubing was reconnected (with buffalo cap attached), but blood immediately backed up into the tubing.A new flush was attached to the buffalo cap to flush, but again it squirted out around the connection point between the cap & end of t-connector.Another new t-connector was placed & tubing re-connected without a buffalo cap.Fluids were resumed with no issues.The bedding under baby's foot with the piv was soaked in blood (approximately 10 cc of blood loss).This incident was noticed at ~0830.The piv had been inserted 3 hours prior & iv fluids initiated at soon before.Per policy, visual inspection of the iv is documented.Previous assessments indicated no leaking.A blood glucose was checked & resulted at 39, & baby was severely jittery & symptomatic.Doctor was notified & a d10w bolus was administered.Follow up blood sugar was 66.The buffalo cap in question & first two t-connectors were saved & inspected.Visible cracks are on both ends of the t-connector where the buffalo cap was attached.".

• Brand Name: SMALLBORE EXTENSION SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6494824
• MDR Text Key: 72876585
• Report Number: 9616066-2017-00586
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20041E
• Device Catalogue Number: 20041E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 20041E, THERAPY DATE (B)(6) 2017
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Weight: 3