MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA KIT W/ Q-SYTE 22GA 1.0IN; IV ADMINISTRATION SET

Catalog Number 383652

Device Problem Difficult or Delayed Activation (2577)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

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.(b)(4).

Event Description

It was reported that 2 bd nexiva¿ kits w/ q-syte¿ 22ga 1.0in experienced safetymechanism/needle disengagement (removal) difficult.The following information was provided by the initial reporter: this is a report about needle retraction failure.After catheter placement, the hcp attempted to withdraw the needle but it was too tight to withdraw it.

Event Description

It was reported that 2 bd nexiva¿ kits w/ q-syte¿ 22ga 1.0in experienced safetymechanism/needle disengagement (removal) difficult.The following information was provided by the initial reporter: this is a report about needle retraction failure.After catheter placement, the hcp attempted to withdraw the needle but it was too tight to withdraw it.

Manufacturer Narrative

H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.

• Brand Name: BD NEXIVA KIT W/ Q-SYTE 22GA 1.0IN
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10989191
• MDR Text Key: 226815964
• Report Number: 9610847-2020-00407
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383652
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1