MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SPECIMEN COLLECTION ASSEMBLY WITH BD¿ BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303380
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
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 a package of bd vacutainer® specimen collection assemblies with bd¿ blunt plastic cannulas had a certification of compliance that contained an expiration date different than that of the package expiration date.
Event or Problem Description
It was reported that a package of bd vacutainer® specimen collection assemblies with bd¿ blunt plastic cannulas had a certification of compliance that contained an expiration date different than that of the package expiration date.
Additional Manufacturer Narrative
Investigation summary: 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 incorrect expiration date on the coc with the incident lot was observed.The photos showed the following: a shelf carton with an expiration date of 2023-07-31.A coc with an expiration date of 2020/07/31.The shelf carton was labeled with the correct expiration date.A review of the device history record was completed for the incident lot 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 most likely cause is that an incorrect year was inadvertently entered on the expiration date when manually entered.

• Brand Name: BD VACUTAINER® SPECIMEN COLLECTION ASSEMBLY WITH BD¿ BLUNT PLASTIC CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8187137
• Report Number: 1024879-2018-01538
• Device Sequence Number: 19361043
• Product Code: FMI
• UDI-Device Identifier: 50382903033800
• UDI-Public: 50382903033800
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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: 07/31/2023
• Device Catalogue Number: 303380
• Device Lot Number: 8197790
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/12/2019
• 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