MAUDE Adverse Event Report: BD MAXPLUS¿ NEEDLELESS POSITIVE PRESSURE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MP1000-C CHINA

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

Mp1000-c (b)(4) 510k: this is an international code - the model# / catalog# identified in is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is mp1000-c.The 510k number provided in is for the domestic similar product: k072542.Medical 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 maxplus¿ needleless positive pressure connector had no medicine flow after connecting the syringe.The following information was provided by the initial reporter, translated from (b)(6) to english: "when used in internal medicine, the joint was ventilated.After connecting the syringe, it was found that no fluid walked and the sample was retained.".

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 20015137.D4: medical device expiration date: 2025-01-07.H4: device manufacture date: 2019-12-19.D10: device available for eval yes.D10: returned to manufacturer on: 2021-09-07.H6: investigation summary: one mp1000-c china sample was received for investigation from lot 20015137; the sample was received without packaging.No sample of the connecting product was received.A visual inspection of the returned samples did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting a retained 50ml bd plastipak syringe from stock to the female luer of the maxplus component; in each instance no flow restriction or occlusion was identified when injecting or expelling fluid.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 20015137 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the exact root cause of the customer's experience in this instance.There were no issues identified during testing of the returned products and it was not possible to identify any manufacturing defects that could have caused or contributed to the customer¿s experience.Previous investigations have identified that certain designs of male luer can cause flow restriction or occlusion as they can grip onto the piston of the maxplus preventing its proper collapse.This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer.However, in this instance the connecting product in clinical use at the time of the incident was not available for investigation; therefore it was not possible to confirm if this may have contributed to the reported issue.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mp1000-c china product in the past 12 months.H3 other text : see h10.

Event Description

It was reported that the bd maxplus¿ needleless positive pressure connector had no medicine flow after connecting the syringe.The following information was provided by the initial reporter, translated from chinese to english: "when used in internal medicine, the joint was ventilated.After connecting the syringe, it was found that no fluid walked and the sample was retained.".

• Brand Name: BD MAXPLUS¿ NEEDLELESS POSITIVE PRESSURE CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12533548
• MDR Text Key: 273574111
• Report Number: 9616066-2021-52129
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K072542
• 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: 09/30/2021

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: MP1000-C CHINA
• Device Lot Number: 20015137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• 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