MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) 25 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

Catalog Number	367335
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/25/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: a sample was not returned for evaluation.One photo was sent that showed the defect.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
Event or Problem Description
It was reported that the 25 g x.75 in.Bd vacutainer® push button blood collection set with 7 in.Tubing and luer adapter had several broken plastic connectors, this resulted in blood leaks during collection.No injury or medical intervention reported.

• Brand Name: 25 G X .75 IN. 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: 7059317
• Report Number: 1024879-2017-00334
• Device Sequence Number: 1301174
• Product Code: JKA
• UDI-Device Identifier: 00382903673353
• UDI-Public: 00382903673353
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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 Catalogue Number: 367335
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2015
• Initial Report FDA Received Date: 11/27/2017
• 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