MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD BLOOD COLLECTION VACUTAINER TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured, bd corporate headquarters in (b)(4) has been listed for the manufacturing site.

Event Description

It was reported when using the unspecified bd blood collection vacutainer tube, the device experienced cracked tube, and sample leakage.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that a gold top tube had a hole in the bottom of the tube which caused it to leak while being spun in centrifuge.Customer problem pin-size hole in bottom of gold top tube; leakage during centrifugation.Sm gold top tube had a pin-size hole in the bottom.

Event Description

It was reported when using the unspecified bd blood collection vacutainer tube, the device experienced cracked tube, and sample leakage.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that a gold top tube had a hole in the bottom of the tube which caused it to leak while being spun in centrifuge.Customer problem pin-size hole in bottom of gold top tube; leakage during centrifugation.Sm gold top tube had a pin-size hole in the bottom.

Manufacturer Narrative

Investigation summary: "material #: 367986.Lot/batch #: 1260853.Bd had not received samples, but a photo was provided for investigation.The photo was reviewed and showed the label on the shrink wrap to verify the complaint batch number.Thirty (30) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to hole in tube as all samples met specifications.Additionally, ten (10) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to leakage 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 of leakage or hole in tube.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.".

• Brand Name: UNSPECIFIED BD BLOOD COLLECTION VACUTAINER TUBE
• 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: 14479507
• MDR Text Key: 292605157
• Report Number: 2243072-2022-00727
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• 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