MAUDE Adverse Event Report: BD CARIBE LTD. BD VACUTAINER® BLOOD TRANSFER DEVICE WITH LUER ADAPTER

Catalog Number 364880

Device Problem Detachment Of Device Component (1104)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Results: a sample is not available for evaluation.¿torque to break¿ and ¿toque to unseat¿ testing was performed on forty retention samples (each test to 20 units) with satisfactory results.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7024720.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.(b)(4).

Event Description

It was reported that an apct was transferring blood from a 20 ml syringe to blood tubes using a bd vacutainer® blood transfer device with luer adapter when the connector tip snapped off and blood sprayed into the apct's face.The apct received post exposure lab work.

• Brand Name: BD VACUTAINER® BLOOD TRANSFER DEVICE WITH LUER ADAPTER
• Type of Device: BLOOD TRANSFER DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6585890
• MDR Text Key: 75815187
• Report Number: 2618282-2017-00004
• Device Sequence Number: 0
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2017

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
• Device Operator: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 364880
• Device Lot Number: 7024720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention