MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION KIT (PEDIATRIC USE); BLOOD COLLECTION SET

Catalog Number 367284

Device Problems Air Leak (1008); Fluid/Blood Leak (1250)

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

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

Results: bd received representative samples and photos from the customer facility for investigation.The actual device was not returned.The samples were evaluated and the customer¿s indicated failure mode for leakage from the wings with the incident lot was not observed.Evaluation of the customers photos showed the reported defect.Additionally, a review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customers¿ indicated failure mode.

Event Description

It was reported that during blood sampling the tube of the bd vacutainer® safety-lok¿ blood collection kit (pediatric use) filled up to 1ml and air bubbles appeared and blood leaked between the wings and the iv needle.Blood sampling had to be stopped.This has been a second incident within 3 days.No serious injury, no medical interventions reported.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION KIT (PEDIATRIC USE)
• 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: 7096965
• MDR Text Key: 94857991
• Report Number: 1024879-2017-01035
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K980414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 367284
• Device Lot Number: 7004810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2017
• 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