MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

Catalog Number 368658

Device Problem Cut In Material (2454)

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

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

Results: bd received six samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for cut tubing with the incident lot was observed.Additionally, a review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: the root cause is multivac knives are cutting into the blister packages and product during the sealing process.Bd has initiated capa (b)(4) to document further investigation and root cause(s) of this product issue.

Event Description

It was reported that the bd vacutainer® push button blood collection set with pre-attached holder had a cut in the tubing before use.No injury or medical intervention.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• 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: 7111266
• MDR Text Key: 94810928
• Report Number: 1024879-2017-01298
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K011984
• 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

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 368658
• Device Lot Number: 5216662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2015
• 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