BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® ONE USE HOLDER; BLOOD SPECIMEN COLLECTION DEVICE
|
Back to Search Results |
|
Catalog Number 364815 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
Hemorrhage/Bleeding (1888)
|
Event Date 04/12/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Medical device expiration date: unknown.(b)(6).A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that the stopper pulled out within holder and the needle stayed inserted in patient.Blood came out of tube and onto phlebotomist, and medical intervention required to stop the bleeding with a bd vacutainer® one use holder.The following information was provided by the initial reporter: this customer has recently moved from reusable holder to one use holder.The customer enquiry was if the diameter of the ouh was smallest than the reusable holder as the tubes seemed tighter in the holder.Below is the account from the customer: blood collection for a patient proceeded as normal, blood flow adequate, no issues identified, patient calm.First tube collected, phlebotomist removed the sst tube ¿ the yellow top remained intact inside the barrel with the needle inside the patient.Blood was spilt from the tube and onto the floor, whilst the needle was still in the arm with the lid of the sst attached, blood continued to flow out of the arm, splashing the collector.The collector then called for help from a colleague.The collector stopped the bleed, removed tourniquet, removed needle and held pressure.Once the needle was disposed of, the collector removed her gloves then washed her hands and arms of the blood.The patient was initially concerned, but remained calm was cleaned up and moved to another room to complete the collection without incident.The phlebotomist has since been tested (routine requirement post needle stick injury) for blood borne diseases, however it has since been ascertained that this was not necessary as her skin is intact and there was no puncture wound.The staff member concerned stated that she held the barrel as she has many times previously, with moderate pressure.Other staff members in the clinic noted that whilst they find the single use barrels tight when using sst tubes, it has been ascertained that this is the first instance of its kind.
|
|
Manufacturer Narrative
|
Bd received samples from the customer facility for investigation.The samples were tested/evaluated and the customer's indicated failure mode for a stopper getting stuck inside a holder was not observed as all product specifications were met.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.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for a stopper getting stuck inside a holder with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
|
|
Event Description
|
It was reported that the stopper pulled out within holder and the needle stayed inserted in patient.Blood came out of tube and onto phlebotomist, and medical intervention required to stop the bleeding with a bd vacutainer® one use holder.The following information was provided by the initial reporter: this customer has recently moved from reusable holder to one use holder.The customer enquiry was if the diameter of the ouh was smallest than the reusable holder as the tubes seemed tighter in the holder.Below is the account from the customer: blood collection for a patient proceeded as normal, blood flow adequate, no issues identified, patient calm.¿ first tube collected, phlebotomist removed the sst tube ¿ the yellow top remained intact inside the barrel with the needle inside the patient.¿ blood was spilt from the tube and onto the floor, whilst the needle was still in the arm with the lid of the sst attached, blood continued to flow out of the arm, splashing the collector.¿ the collector then called for help from a colleague.¿ the collector stopped the bleed, removed tourniquet, removed needle and held pressure.¿ once the needle was disposed of, the collector removed her gloves then washed her hands and arms of the blood.¿ the patient was initially concerned, but remained calm was cleaned up and moved to another room to complete the collection without incident.¿ the phlebotomist has since been tested (routine requirement post needle stick injury) for blood borne diseases, however it has since been ascertained that this was not necessary as her skin is intact and there was no puncture wound.¿ the staff member concerned stated that she held the barrel as she has many times previously, with moderate pressure.¿ other staff members in the clinic noted that whilst they find the single use barrels tight when using sst tubes, it has been ascertained that this is the first instance of its kind.
|
|
Search Alerts/Recalls
|
|
|