MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SAFETY-LOK¿ BCS WITH PRE-ATTACHED HOLDER, 21G 7IN TUBE; BLOOD COLLECTION NEEDLE

Catalog Number 368654

Device Problems Detachment Of Device Component (1104); Device Slipped (1584)

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

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).Five customer samples were received in sealed packages.Visual inspection of the returned customer samples identified two samples with iv protectors loose in the packages.Three customer returned samples were received with the iv protectors not loose in the packages.Conclusion: root cause: excessive lubricant on the air knives due to wings stuck in cascade trough which resulted in lubricant on the wing nose.Corrective action: the wings were removed from the cascade trough and the air knives trough was cleaned at the soltrol cascade lube machine.Preventive action: a pneumatic blow-off station was added at station 11 (soltrol cascade machine) to avoid wings being stuck in the cascade trough.Target date for completion of project is scheduled for 12/31/2015.

Event Description

It was reported that before use, while opening bd vacutainer® safety-lok¿ bcs with pre-attached holder, 21g 7in tube several different users experienced clean needle sticks due to loose iv protectors.The safety lock has become detached in the packaging and on several different occasions opening the package has resulted in clean needle sticks.For each of these occasions no medical intervention was reported.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BCS WITH PRE-ATTACHED HOLDER, 21G 7IN TUBE
• Type of Device: BLOOD COLLECTION NEEDLE
• 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: 6999820
• MDR Text Key: 92201110
• Report Number: 1024879-2017-00211
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K980414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 368654
• Device Lot Number: 5160893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• 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