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U.S. Department of Health and Human Services

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

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BD MAXPLUS¿ NEEDLELESS POSITIVE PRESSURE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
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.".
 
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Brand Name
BD MAXPLUS¿ NEEDLELESS POSITIVE PRESSURE CONNECTOR
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12533548
MDR Text Key273574111
Report Number9616066-2021-52129
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K072542
Number of Events Reported1
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 NumberMP1000-C CHINA
Device Lot Number20015137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Initial Date Manufacturer Received 08/30/2021
Initial Date FDA Received09/27/2021
Supplement Dates Manufacturer Received09/30/2021
Supplement Dates FDA Received10/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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