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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON NON-VENTED MALE LL CAP INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON NON-VENTED MALE LL CAP INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 1008-000-116
Device Problems Leak/Splash (1354); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacturer: (b)(4). There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0004125870, medical device expiration date: na, device manufacture date: 2020-04-11, medical device lot #: 0004125877, medical device expiration date: na, device manufacture date: 2020-05-23, medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown. Investigation summary: seven photos and two male luer caps, model 1008-000-116 lots 0004125870 and 0004125877, were received for investigation. Upon visual inspection under magnification of the sample for lot 0004125870, it could be observed that there was a small indent that looked like a pin hole on the luer. No other defects were observed. The customer's complaint of a pin hole in the luer cap was verified. Upon visual inspection under magnification of the sample for lot 0004125877, it could be observed that there was a shallow scratch on the surface of the male luer cap. No other defects were observed. The customer's complaint of a pin hole in the luer cap could not be verified. The photos received were not clear enough to provide any additional information. Three additional samples were also received at the north america molding center (namc ) and appeared to be similar in appearance condition to the samples previously mentioned. Both male luer caps were then functionally tested for leakage under 30 psi. No evidence of leakage was seen. While there was a nick on both luer caps, the damage was not deep or large enough to allow fluid through, and the customer's complaint of leakage through the cap could not be verified. The root cause of the damaged luer lock cap is unknown. The mold was transferred from vyaire to the north american molding center (namc) on august 2020, it disassembled, inspected and cleaned. These inspections and if necessary, corrections are done to all vyaire transfer molds received at the namc before the mold runs. The product reported was manufactured by supplier (vyaire) and manufacturing information was requested. The supplier conducted a dhr review of model 1008-000-116, lots 0004125870 and 0004125877, and no issues were found during the manufacturing of the reported lots. No immediate action was required since the mold was relocated to site bd namc and no issues have been found during manufacturing, however, a notification of the complaint was submitted to bd namc on 10aug2021. Additionally, namc has controls in place to detect this defect condition, make corrections to the tool and process, and prevent the release of defects to the customer. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that 1 non-vented male ll cap each from lots 0004125870, 0004125877, and an unspecified lot had pin holes in them that caused leakage. The following information was provided by the initial reporter: "prior to use of the custom tubing pack the customer noted that one of the luer caps on the cardioplegia set had a "pin hole" in it that caused leaking. The cap was switched for a new luer cap for the procedure. There was not patient involvement so no adverse patient effects occurred. ".
 
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Brand NameNON-VENTED MALE LL CAP
Type of DeviceINTRAVASCULAR 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12392429
MDR Text Key268954023
Report Number2243072-2021-02198
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number1008-000-116
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
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

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