MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367288

Device Problems Product Quality Problem (1506); Obstruction of Flow (2423)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is nipro.This site is an oem manufacturing site.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.During our manufacturing process, molding parts such as the safety shields or the wing needle hubs are inspected per a lot and only the conforming parts will be used for the assembly.In addition, the appearance and the functionality are checked for all product lots as process inspections and release inspections.Therefore, the possibility that defective products are flowed to the next process or shipped out is very low.As stated in the ifu, please hold the end of safety shield and tubing (avoid holding the wings together) and slide the safety shield straight to cover the winged needle without holding wings.Under our manufacturing process, inspections are performed for all the products by automatic blockage inspection machine installed on our automatic assembling machine after adhering luer adaptor hubs and needle tubes, and after adhering wing needle hubs, tubes and connecters.Moreover, inspection machines are routinely checked and maintained.Therefore, the possibility that clogged products are flowed and shipped out is very low.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was slow flow and a clogged/blocked cannula(s).The following information was provided by the initial reporter.The customer stated: "the blood draw is extremely slow and due to the yellow safety they are awkward to use.".

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 15983475
• MDR Text Key: 307015988
• Report Number: 2243072-2022-02155
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367288
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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