MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) 21 G X 0.75 IN. BD VACUTAINE® SAFETY-LOK¿ BLOOD COLLECTION SET

Catalog Number 367282

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

Results - bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for leaking with the incident lot was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that blood didn't flow into the collection set of the 21 g x 0.75 in.Bd vacutaine® safety-lok¿ blood collection set and leaked.There was air inside the sample and the tube stopped to fill.The same happened with another needle from the same lot: the venepuncture was done 3 times.No injury or medical intervention reported.

• Brand Name: 21 G X 0.75 IN. BD VACUTAINE® SAFETY-LOK¿ BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7059209
• MDR Text Key: 93690475
• Report Number: 1024879-2017-00908
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Phlebotomist
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 367282
• Device Lot Number: 6112768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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): Other