MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT 22GA 1.00IN (0.9 MM X 25 MM); INTRAVASCULAR CATHETER

Catalog Number 383532

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that an unspecified number of bd nexiva dual port 22ga 1.00in (0.9 mm x 25 mm) experienced a mix of product types in a pack which was noted prior to use.The following information was provided by the initial reporter: material no.: 383532, batch no.: unknown.Per complaint form: a nurse had identified multiple single port bd nexiva catheters mixed in with the dual port unit stock.The packaging of all items in this complaint did not contain a q-syte (missing part).There was 1 dual port 22g bd nexiva catheter identified to also be missing a q-syte.This is the only package that was opened by the nurse.All others (the single port catheters) have closed packaging.

Event Description

It was reported that an unspecified number of bd nexiva dual port 22ga 1.00in (0.9 mm x 25 mm) experienced a mix of product types in a pack which was noted prior to use.The following information was provided by the initial reporter: material no.: 383532, batch no.: unknown.Per complaint form: a nurse had identified multiple single port bd nexiva catheters mixed in with the dual port unit stock.The packaging of all items in this complaint did not contain a q-syte (missing part).There was 1 dual port 22g bd nexiva catheter identified to also be missing a q-syte.This is the only package that was opened by the nurse.All others (the single port catheters) have closed packaging.

Manufacturer Narrative

H.6.Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The complaint was deemed as mdr reportable therefore a submission will be performed.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.H3 other text : see section h.10.

• Brand Name: BD NEXIVA DUAL PORT 22GA 1.00IN (0.9 MM X 25 MM)
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9355746
• MDR Text Key: 178179253
• Report Number: 1710034-2019-01241
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835325
• UDI-Public: 30382903835325
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• 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: 12/10/2019

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 Catalogue Number: 383532
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other