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

Catalog Number	367335
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that mixed product occurred before use with a bd vacutainer ® push button blood collection set.The following information was provided by the initial reporter, when i opened the box i noticed some red text and corner arrow on one of the devices, it is situated as a singular ultra-touch device in the box.Code 367391 bd vacutainer ultratouch push button blood collection set 25 g 7 inch tube the box product code is 367335 and lot number 8344580.The box was sealed closed by supply chain and had not been opened before being delivered to my office.".
Event or Problem Description
It was reported that mixed product occurred before use with a bd vacutainer ® push button blood collection set.The following information was provided by the initial reporter, "when i opened the box i noticed some red text and corner arrow on one of the devices, it is situated as a singular ultra-touch device in the box.Code 367391 bd vacutainer ultratouch pushbutton blood collection set 25g 7inch tube the box product code is 367335 and lot number 8344580.The box was sealed closed by supply chain and had not been opened before being delivered to my office.".
Additional Manufacturer Narrative
Investigation: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for different catalog numbers within the shelf pack was observed.A review of the device history record was completed for one of the incident lots and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.The second catalog and lot number were not provided, and therefore a device history record review could not be conducted.

• Brand Name: BD VACUTAINER ® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8994756
• Report Number: 1024879-2019-01621
• Device Sequence Number: 11470743
• Product Code: JKA
• UDI-Device Identifier: 00382903673353
• UDI-Public: 382903673353
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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
• Operator of Device: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 367335
• Device Lot Number: 8344580
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other