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

Catalog Number 364880

Device Problems Structural Problem (2506); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown investigation: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.

Event Description

It was reported that the non-patient end need on a bd vacutainer® blood transfer device with luer adapter was out of the sleeve before use.There was no report of injury or medical interventions.

• Brand Name: BD VACUTAINER® BLOOD TRANSFER DEVICE WITH LUER ADAPTER
• Type of Device: BLOOD COLLECTION SET
• 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: 7225980
• MDR Text Key: 98678562
• Report Number: 2618282-2018-00002
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903648806
• UDI-Public: 50382903648806
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364880
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other