MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

Catalog Number	367285
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacture date: unknown.Bd received 1 sample and 8 photos from the customer facility for investigation.Based on the visual inspection of the sample, bd observed foreign matter on both the outside and inside of the sealed blister package.Further analysis of the sample confirmed that the foreign matter exhibited properties that were consistent with human blood.Additionally, 50 retention samples were selected from in-house inventory and inspected for the presence of foreign matter, and no issues were observed as all retention samples met specifications.The manufacturing records were reviewed for the incident lot and no issues were identified.Conclusion: the complaint is confirmed.Training has been issued to employees about what to do if hurt at work.
Event or Problem Description
It was reported that a bd vacutainer® safety-lok¿ blood collection set had presence of blood inside and outside of the packaging.It was reported to be hermetically sealed.There was no report of serious injury or medical intervention.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7088010
• Report Number: 2243072-2017-00293
• Device Sequence Number: 1895409
• Product Code: JKA
• UDI-Device Identifier: 00382903672851
• UDI-Public: 00382903672851
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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
• Operator of Device: Other
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 367285
• Device Lot Number: 5G2411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 12/06/2017
• 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