MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE.

Catalog Number 368652

Device Problems Cut In Material (2454); Device Packaging Compromised (2916)

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

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Results: photos and actual sample were returned for evaluation showing the defect.Bd was able to confirm customer's indicated failure mode.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5236544.Conclusion: root cause is multivac knives are cutting into the blister packages and product during the sealing process.Capa (b)(4) has been opened to document the investigation path and corrective/preventative actions taken to remediate this defect.

Event Description

It was reported that the g x.75 in.Bd vacutainer® push button blood collection set with 12 in.Tubing and pre-attached holder was cut off in the package.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE.
• 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: 7077111
• MDR Text Key: 94109586
• Report Number: 1024879-2017-00824
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903686520
• UDI-Public: 382903686520
• 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: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 368652
• Device Lot Number: 5236544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2015
• 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