MAUDE Adverse Event Report: BECTON DICKINSON BD NEUTRACLEAR¿ 2-WAY EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number PY2101NCM

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: the manufacturing location for this product is cair.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in sections manufacturer name, city and state and manufacturer site and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot #: an invalid lot # of 22a03-tc was provided by the initial reporter.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 the bd neutraclear¿ 2-way extension set was clogged.The following information was provided by the initial reporter: when giving bolus medication, the line appears to be blocked.However, the line does spray through but the orange rubber blocks.It does not "spring back".So the line could be blocked because the medication is no longer being delivered.Now this was only nacl, but with cardiotics it is a big problem.

Event Description

It was reported that the bd neutraclear¿ 2-way extension set was clogged.The following information was provided by the initial reporter: when giving bolus medication, the line appears to be blocked.However, the line does spray through but the orange rubber blocks.It does not "spring back".So the line could be blocked because the medication is no longer being delivered.Now this was only nacl, but with cardiotics it is a big problem.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 15-sep-2022.H6: investigation summary: two py2101ncm samples from lot 22a03-tc were received without packaging for investigation; residual fluid was visible in the devices.The samples were received alongside a glass pre-filled syringe of metoclopramide.A visual inspection of the returned samples confirmed the customer's experience, as the pistons of the neutraclears of each sample were noted to be recessed.The details of this feedback were shared with the legal manufacturer of the product, cair lgl for investigation.Their analysis confirmed that three of the four neutraclear components had a recessed piston; a closer inspection of the components identified that the internal needle of the neutraclears had been damaged.Furthermore they analysed the male luer of the returned syringe, which confirmed that it was incompatible for use with the neutraclear® valve; in this instance it is likely that the internal needle of the neutraclear was damaged during connection with returned syringe, resulting in the piston remaining recessed upon disconnection.A review of the production records for lot 22a03-tc did not identify any in-process testing issues or quality deviations which may have resulted in a report of this nature.

• Brand Name: BD NEUTRACLEAR¿ 2-WAY EXTENSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14992443
• MDR Text Key: 303065053
• Report Number: 2243072-2022-00940
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: PY2101NCM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• 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