MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367338

Device Problem Break (1069)

Patient Problems Erythema (1840); Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: fpa.Medical device type: intravascular administration set.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 that the bd vacutainer® push button blood collection set would not draw blood after puncturing the patient's left arm, and the needle, while still in the patient's vein, was retracted before being placed in the sharps bin.A new bd vacutainer® push button blood collection set was then used in the right arm, where blood was successfully drawn.Two days later, the patient returned to the hospital, claiming "she felt redness and heat pain and press pain" in the left arm above where the failed venipuncture had taken place.Due to the late time, the hospital set up a consultation the following afternoon, where the patient underwent an x-ray diagnosis.A "6mm" piece of metal was found on the x-ray film in the patient's left arm, but it was not determined if the foreign metal piece was part of the blood collection set needle used there a few days prior.A bd sales rep was called into the hospital the same day, where an investigation was undertaken, but no fractured iv needle was found in the sharps bin where the needle in question had been deposited.Currently, the patient is "not willing to take the initiative" to contact the hospital, nor willing to undergo surgery to remove the foreign metal object from the body.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2019, a female(b)(6) years old patient came to hospital for medical examination.Hospital nurse then use bd pbbcs to withdraw blood.Nurse first puncture patient's left arm, the puncture point was normally site which conduct the venipuncture, after puncture, no blood came out, nurse then "probing" at the venipuncture site, and no blood came out either.Nurse then activated the press the push button (needle cannula still in patient's body this time), and put this pbbcs into the sharp bin.Nurse then took a new pbbcs and tried to withdraw blood from the patient's right arm.After puncture, blood came out, and successfully finished blood draw.After finished blood draw, the patient feel nothing abnormal, and continue the rest medical examination project hospital.On (b)(6) 2019 afternoon, this patient came back to hospital and claim she felt redness and heat pain and press pain above the left arm venipuncture site.Due to late that time, hospital decide to consultation this patient on (b)(6) 2019 3:00 p.M.On (b)(6) 2019 3:00 p.M.Hospital give this patient x-ray diagnosis.And found there is a piece of metal nearly 6mm in patient's left arm on the x-ray film.Hospital then doubt the metal foreign was a part of bd pbbcs iv needle cannula, and ask bd local sales came to hospital.On 3/29/2019 night, bd local sales came to hospital to understand the situation and conduct some investigation, the result is local sales didn't find any iv needle cannula which is fracture in the sharp bin.Until now (4/1/2019 8:03 p.M.), the patient is not willing to take the initiative to contact the hospital, and this patient not willing to take a surgery to take the foreign metal out of the body.".

Event Description

It was reported that the bd vacutainer® push button blood collection set would not draw blood after puncturing the patient's left arm, and the needle, while still in the patients vein, was retracted before being placed in the sharps bin.A new bd vacutainer® push button blood collection set was then used in the right arm, where blood was successfully drawn.Two days later, the patient returned to the hospital, claiming "she felt redness and heat pain and press pain" in the left arm above where the failed venipuncture had taken place.Due to the late time, the hospital set up a consultation the following afternoon, where the patient underwent an x-ray diagnosis.A "6mm" piece of metal was found on the x-ray film in the patients left arm, but it was not determined if the foreign metal piece was part of the blood collection set needle used there a few days prior.A bd sales rep was called into the hospital the same day, where an investigation was undertaken, but no fractured iv needle was found in the sharps bin where the needle in question had been deposited.Currently, the patient is "not willing to take the initiative" to contact the hospital, nor willing to undergo surgery to remove the foreign metal object from the body.The following information was provided by the initial reporter, translated from chinese to english: "on (b)(6) 2019, a female 27 years old patient came to hospital for medical examination.Hospital nurse then use bd pbbcs to withdraw blood.Nurse first puncture patients left arm, the puncture point was normally site which conduct the venipuncture, after puncture, no blood came out, nurse then "probing" at the venipuncture site, and no blood came out either.Nurse then activated the press the push button (needle cannula still in patient's body this time), and put this pbbcs into the sharp bin.Nurse then took a new pbbcs and tried to withdraw blood from the patient's right arm.After puncture, blood came out, and successfully finished blood draw.After finished blood draw, the patient feel nothing unnormal, and continue the rest medical examination project hospital.(b)(6) 2019 afternoon, this ptient came back to hospital and claim she felt redness and heat pain and press pain above the left arm venipuncture site.Due to late that time, hospital decide to consultation this patient on (b)(6) 2019 3:00 p.M.On (b)(6) 2019 3:00 p.M.Hospital give this patient x-ray diagnosis.And found there is a piece of metal nearly 6mm in patient's left arm on the x-ray film.Hospital then doubt the metal foreign was a part of bd pbbcs iv needle cannula, and ask bd local sales came to hospital.On (b)(6) 2019 night, bd local sales came to hospital to understand the situation and conduct some investigation, the result is local sales didn't found any iv needle cannula which is fracture in the sharp bin.Until now (b)(6) 2019 8:03 p.M.), the patient is not willing to take the initiative to contact the hospital, and this patient not willing to take a surgery to take the foreign metal out of the body.".

Manufacturer Narrative

Investigation summary: bd had not received samples, but photos of an x-ray were provided by the customer facility for investigation.The photos were evaluated and an unknown object was observed in the patient's arm.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for iv cannula fracture with the incident lot could not be confirmed.Root cause description: based on the investigation, a root cause could not be determined.Rationale: 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.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8515362
• MDR Text Key: 142042055
• Report Number: 1710034-2019-00416
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673389
• UDI-Public: 50382903673389
• Combination Product (y/n): N
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 367338
• Device Lot Number: 8193826
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR