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

Catalog Number 364880

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

Results: a sample was not returned for evaluation.Bd received 5 photos from the customer facility for investigation.It was confirmed that the sleeve was trapped in the terumo tube.Nevertheless, the terumo product used in conjunction with our btd and other acquisition products sometimes is incompatible due to the design of the foil closure of the tube which is comprised of a centralize small hard septum surrounded by a stiff thin foil closure.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 Description

It was reported that bd vacutainer® blood transfer device with luer adapter had a detached rubber sleeve of np needle.Blood leaked when used with the terumo tube.No serious injury or medical intervention reported.

• 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: 7088434
• MDR Text Key: 94801240
• Report Number: 2618282-2017-00032
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903648801
• UDI-Public: 00382903648801
• 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: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• 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: 02/07/2017
• 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