MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON SET WITH 12 IN. TUBING AND HOLDER (23GX.75"); BLOOD COLLECTION SET

Catalog Number 368658

Device Problem Device Inoperable (1663)

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

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field of 10/28/2016.Results: bd had not received samples or photos from the customer facility for evaluation in support of this complaint; therefore, the investigation was limited.A review of the manufacturing records (dhr) was completed for the incident lot and no issues were identified.Refer to capa (b)(4).Conclusion: confirmed complaint.Bd was able to confirm customers' indicated failure mode for severed tubing.A capa (b)(4) investigation has been initiated for severed tubing.Initial investigation ¿root cause¿ indicated tubing caught in the seal of the multivac (packaging machine) when the blisters are cut apart.Refer to capa (b)(4).

Event Description

It was reported that the customer has been having a lot of issues with the tubing from the bd vacutainer® push button sets with 12 in.Tubing and holder (23 g x.75 in.).No serious injury, blood to mucous membrane exposure or medical intervention was reported.

• Brand Name: BD VACUTAINER® PUSH BUTTON SET WITH 12 IN. TUBING AND HOLDER (23GX.75")
• 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: 7101484
• MDR Text Key: 95057774
• Report Number: 1024879-2017-00932
• 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,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/24/2017

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: 12/31/2017
• Device Catalogue Number: 368658
• Device Lot Number: 6007666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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