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

Catalog Number 367284

Device Problem Volume Accuracy Problem (1675)

Patient Problems Syncope (1610); Headache (1880); Tissue Damage (2104); Convulsion, Clonic (2222)

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.The reported lot # [9c17b1] was not found for the reported catalog # [367284].Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that blood flow stopped through the bd vacutainer® safety-lok¿ blood collection set during use after "3 drips." the tube was changed out, and the device adjusted "3 times", making the puncture hole "significantly increase" in the patient's arm.After "10 minutes" of this "interference," the patient suffered a "vasovagal syncope, including myoclonic jerking and urination." the hospital resuscitation team was dispatched "within minutes", but the patient reportedly made a "spontaneous" recovery without the need of intervention.The blood test became a "6 hour ordeal" to "exclude the possibility of a convulsive seizure." a second collection was performed with a different box of bd vacutainer® safety-lok¿ blood collection sets which reportedly "worked without issue." the following information was provided by the initial reporter: i took my daughter to the hospital for a routine blood collection in the phlebotomy department.The phlebotomist proceeded to use a safety lok and vacutainers to attempt to collect blood.However after 3 drips of blood into the first tube no further flow was observed.The phlebotomist then changed tubes and with a different type of tube (orange cap to purple cap) there was still no flow.Assuming he had made a mistake with installation of the safety lock he then tried to adjust the device 3 times causing the puncture hole to significantly increase in my daughter¿s arm.At this point, after approximately 10 minutes of interference my daughter suffered a vasovagal syncope, including myoclonic jerking and urination over her clothing & mine.The hospital reacted immediately with a resuscitation team deployed within minutes, although my daughter made a spontaneous recovery without the need for intervention.She awoke distressed and with a significant headache.A routine blood test then became a 6 hour ordeal as the hospital wanted to exclude the possibility of a convulsive seizure.Once my daughter ¿recovered¿ from the syncope a different phlebotomist informed us that this box of safety-lok had failed to work correctly on three occasions during that day.At that point i requested the box be segregated and given to the hospital complaints handling team for escalation, i identified myself as a bd employee and photographed the box and blister.I have requested they submit the failed device alongside their own complaint.A repeat blood collection was performed using a fresh box of safety-lok and worked immediately without issue (or need for adjustment) from the original phlebotomist.I did not note the batch details of the operational box as my primary concern was my daughter¿s welfare.

Manufacturer Narrative

Investigation: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to insufficient blood flow as all samples met specifications.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.

Event Description

It was reported that blood flow stopped through the bd vacutainer® safety-lok¿ blood collection set during use after "3 drips".The tube was changed out, and the device adjusted "3 times", making the puncture hole "significantly increase" in the patient's arm.After "10 minutes" of this "interference", the patient suffered a "vasovagal syncope, including myoclonic jerking and urination".The hospital resuscitation team was dispatched "within minutes", but the patient reportedly made a "spontaneous" recovery without the need of intervention.The blood test became a "6 hour ordeal" to "exclude the possibility of a convulsive seizure".A second collection was performed with a different box of bd vacutainer® safety-lok¿ blood collection sets which reportedly "worked without issue".

• 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
• MDR Report Key: 8961692
• MDR Text Key: 156627988
• Report Number: 2243072-2019-01891
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 367284
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR