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

Catalog Number 367283

Device Problems Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set, the device experienced difficulty activating the safety shield, and the cannula broke off or pulled out during use.The following information was provided by the initial reporter.The customer stated: it was reported by the customer the needle broke off in a patient's arm, the safety device would not deploy needle was loose.Did any hazard occur (e.G.Exposure to blood/bodily fluid, needle/probe stick, safety issue)? yes.If yes¿detailed hazard including any medical intervention: needle broke off and became loose while in patient's arm.Needle was retrieved but patient had a small bruise.(b)(6).Customer reports safety device that would not deploy and needles that are loose and broke while in the patient's arm for cat 367283 lot 2a3b1.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to loose needle/failed safety as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure modes.Bd was not able to identify a root cause for the indicated failure modes.As stated in the ifu, please activate the safety shield after pulling the needle out of patient¿s arm.To activate, please hold the end of safety shield and tubing, and slide the safety shield straight to cover the winged needle without holding wings.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set, the device experienced difficulty activating the safety shield, and the cannula broke off or pulled out during use.The following information was provided by the initial reporter.The customer stated: it was reported by the customer the needle broke off in a patient's arm, the safety device would not deploy needle was loose.Did any hazard occur (e.G.Exposure to blood/bodily fluid, needle/probe stick, safety issue)? yes.If yes¿detailed hazard including any medical intervention: needle broke off and became loose while in patient's arm.Needle was retrieved but patient had a small bruise.(b)(6) 2022 16:19:53 (gmt).Customer reports safety device that would not deploy and needles that are loose and broke while in the patient's arm for cat 367283 lot 2a3b1.

• 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: 15638679
• MDR Text Key: 302086918
• Report Number: 2243072-2022-01801
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903672837
• UDI-Public: 00382903672837
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367283
• Device Lot Number: 2A30B1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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
• Patient Outcome(s): Required Intervention