MAUDE Adverse Event Report: CAREFUSION UNSPECIFIED BD SMART SITE

Model Number 2426-0500

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ smart site leaked.The following information was provided by the initial reporter: material #: unknown batch #: unknown.It was reported a smart site was found leaking on a picc line causing it to occlude.Smart site was found leaking on a picc line causing it to occlude and have to be discontinued.This, sadly, was on a very unstable (b)(6) gestation baby who had to have a new central line placed due to this issue.

Manufacturer Narrative

The complaint of leakage was received from the customer.Because no sample was received the complaint could not be verified.A device history record review could not be performed because a model or lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that unspecified bd¿ smart site leaked.The following information was provided by the initial reporter: material #: unknown.Batch #: unknown.It was reported a smart site was found leaking on a picc line causing it to occlude.Smart site was found leaking on a picc line causing it to occlude and have to be discontinued.This, sadly, was on a very unstable 23 week gestation baby who had to have a new central line placed due to this issue.

Event Description

It was reported that unspecified bd¿ smart site leaked.The following information was provided by the initial reporter: material #: unknown batch #: unknown.It was reported a smart site was found leaking on a picc line causing it to occlude.Smart site was found leaking on a picc line causing it to occlude and have to be discontinued.This, sadly, was on a very unstable 23 week gestation baby who had to have a new central line placed due to this issue.

Manufacturer Narrative

The following fields were updated due to additional information: d4: model # 2426-0500; d4: catalog # 2426-0500; d4: lot # 20043369; d4: udi # 761303020992; d4: device expiration date 04/14/2023.D10: device available for eval yes; d10: returned to manufacturer on: 09/09/2020.H4: device manufacture date: 04/14/2020.Investigation conclusion: it was reported a smart site was found leaking on a picc line causing it to occlude.Received from the customer is one used primary set model 2426-0500 lot 20043369.Attached to the set¿s drip chamber spike is a 100ml fresenius kabi bag lot 12pbm03 exp 02-2022, magnesium sulfate in 5% dextrose injection 1g total in 100ml.Visual inspection was performed on the set to look for defects such as cracks, deformations, misassemblies.No anomalies were observed on the set during initial visual inspection.Functional testing was performed by filling a lab iv bag with blue dye water and attaching it to the set allowing fluid to flow through the whole set via gravity.A leak was observed from the distal smartsite (p/n 12274436).No occlusions were observed throughout the set.Closer inspection of the smartsite leak under a lab microscope observed that the smartsite piston was not in its fully closed state.A lab syringe was used to engage and then disengage from the distal smartsite in an attempt to return the smartsite piston to a fully closed state.After multiple engages and disengages the smartsite piston still did not return to a fully closed state.No further testing could be performed due to the set leaking.This issue was escalated to bd nogales manufacturing for further investigation.Equipment used for testing on 21sep2020: optical ram-cnc eq 08204 5-feb-21 a device history record for model 2426-0500 with lot number 20043369 was performed.The search showed that a total of 34,563 units in 1 lot number were built on 14apr2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The customer¿s report of a smartsite leak was confirmed.The root cause of the smartsite leak was identified as due to machine process issue during the smartsite assembly.The customer¿s report of an occlusion was not confirmed.The root cause of the customer¿s report could not be determined as no occlusions were replicated throughout the received set.

• Brand Name: UNSPECIFIED BD SMART SITE
• Type of Device: SMART SITE
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10236635
• MDR Text Key: 197748527
• Report Number: 9616066-2020-02145
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/14/2023
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 20043369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 20200605; 20200605
• Patient Outcome(s): Other