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

Catalog Number 367288

Device Problems Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/10/2022

Event Type  Injury  

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set safety shield was not properly engaged and needle scratched phlebotomist's finger.The following information was provided by the initial reporter.The customer stated: ¿withdrawal of needle and activation of the safety shield of wingset was performed by pulling on the tubing while the needle was in vein.This process was interrupted by patient applying pressure to venipuncture point.Safety shield was not properly engaged and needle scratched phlebotomist's finger.".

Manufacturer Narrative

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.As it was reported that the customer didn¿t activate the safety shield properly, it was considered that there was nothing wrong with the product.Moreover, no abnormalities that could lead to a malfunction of the safety shield were found from reviewing the manufacturing and inspection records.As stated in the ifu, please hold the end of safety shield but not the tubing when withdrawing the needle from patients.For the safety shield activation, please hold the end of the safety shield and slide the safety shield straight to cover the needle." medical device expiration date: unknown.Device manufacture date: unknown.(b)(6).Oem manufacturer: (b)(4).

• 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: 15798138
• MDR Text Key: 303650165
• Report Number: 2243072-2022-01952
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• 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: 10/28/2022
• 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