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

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.".

• Brand Name: NON-VENTED MALE LL CAP
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12392429
• MDR Text Key: 268954023
• Report Number: 2243072-2021-02198
• 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: distributor,foreign,other
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1008-000-116
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Date Manufacturer Received: 08/02/2021
• 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
• Patient Sequence Number: 1