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

Catalog Number 368654

Device Problems Component Falling (1105); Loose or Intermittent Connection (1371); Packaging Problem (3007)

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

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Initial reporter phone #: (b)(6).Results: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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 the needle protector of bd vacutainer® safety-lok¿ bcs with pre-attached holder, 21g 7in tube was loose or fell off in the packaging.No injury or medical intervention.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BCS WITH PRE-ATTACHED HOLDER
• 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: 7113591
• MDR Text Key: 94880436
• Report Number: 1024879-2017-01293
• 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: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 5162999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2015
• 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