MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK BLOOD COLLECTION SET; BLOOD COLLECTION/INTRAVENOUS FLUID ADMINISTRATION SET

Catalog Number	367294
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in sections and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.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 bd vacutainer® safety-lok blood collection set was missing luer adapter.
Event or Problem Description
It was reported that a bd vacutainer® safety-lok blood collection set was missing the holder.
Additional Manufacturer Narrative
The following field has been updated due to corrected information: b.5.Describe event or problem: it was reported that a bd vacutainer® safety-lok blood collection set was missing the holder.Due to the corrected information this complaint is not reportable.A holder missing would render the device unusable prior to use, requiring replacement.Complaint # 2243072-2019-00127 is null and void as a result.

• Brand Name: BD VACUTAINER® SAFETY-LOK BLOOD COLLECTION SET
• Common Device Name: BLOOD COLLECTION/INTRAVENOUS FLUID ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8283541
• Report Number: 2243072-2019-00127
• Device Sequence Number: 1946703
• Product Code: JKA
• UDI-Device Identifier: 50382903672948
• UDI-Public: 50382903672948
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K991088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 04/30/2020
• Device Catalogue Number: 367294
• Device Lot Number: 7D28A1
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/20/2019
• 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