MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383532

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use a bd nexiva¿ closed iv catheter system malfunctioned as "the needle become stuck on removal, which then resulted in us having to fully remove the cannula and re-cannulate the child again." there was no report of exposure, injury or medical intervention needed.

Event Description

It was reported that during use a bd nexiva¿ closed iv catheter system malfunctioned as "the needle become stuck on removal, which then resulted in us having to fully remove the cannula and re-cannulate the child again." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Device/batch history record review: the lot was built and packaged on nfa line 2 from 20oct2017 through 25oct2017 for the quantity of (b)(4).All required challenge samples and testing during the build of the catheters was performed per specifications, in accordance with the in-process sampling plans.A related qn (see attached) for ¿failed retraction¿ was initiated; disposition of the product, root cause and corrective action were applied according to the quality control plan.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Observations and testing: received 2 nexiva 22ga units.Unit 1: received an unused unit where all the components were present.The unit was received along with a piece of top web (packaging) from lot number: 7290663.Unit 2: received a used unit where the needle was fully disengaged but the catheter was still attached to the tip shield.The unit was received along with a piece of top web (packaging) from lot number: 7290663.Simulation test (disengagement): unit 1: simulation test was performed and successfully disengaged and the adapter was released without resistance.No adhesive or physical-mechanical damage was found on any of the components of the unit.Unit 2: simulation test was performed and although the cannula successfully disengaged without resistance and the safety mechanism was applied, the adapted stayed attached to the tip shield.Visual/microscopic examination: revealed traces of cured adhesive on several locations throughout the tip shield preventing the adapter from decoupling.The needle fully disengaged and the safety mechanism functioned as expected.The failure described in the incident report was caused when cured adhesive ¿bonded¿ the tip shield and adapter preventing it from decoupling.Per qn the failure was initiated due to machine wear (o rings worn out).Corrective action was applied.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7570540
• MDR Text Key: 110346214
• Report Number: 1710034-2018-00262
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835325
• UDI-Public: 30382903835325
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 383532
• Device Lot Number: 7290663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other