MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 13X75 MM 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE; BLOOD COLLECTION TUBE

Catalog Number 367861

Device Problem Low Test Results (2458)

Patient Problems Venipuncture (2129); Test Result (2695)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Results: a sample was not returned for evaluation.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.(b)(4).

Event Description

It was reported that a nursing home patient's hgb test results were critically low at 6.9.A 13 x 75 mm 4.0 ml bd vacutainer® plus plastic whole blood tube was used for this test.The patient was transferred to a hospital where repeat testing was done and the hgb result was 8.9.The test results were identified as an issue with the patient's condition being that he/she was edematous with 40 pounds worth of fluid.

Manufacturer Narrative

Additional information: three lot numbers for this incident were provided.The information for each lot number is as follows: medical device lot #: 6253706, expiration date: 1/31/2018, manufacture date: 9/92016.Medical device lot #: 6253709, expiration date: 1/31/2018, manufacture date: 9/9/2016.Medical device lot #: 6253710, expiration date: 1/31/2018, manufacture date: 9/9/2016.Device evaluation: results: bd did not receive samples or photos from the customer facility for investigation.Therefore, retention samples from the incident lots were selected for testing.All tubes performed as expected and no product issues were observed during the investigation.A review of the device history record was completed for the incident lot numbers and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Conclusion: based on the investigation, a root cause could not be determined.The results of internal testing show acceptable performance.Based on follow up with the customer, patient conditions were a potential root cause for the reported elevated reading.

• Brand Name: 13X75 MM 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6742038
• MDR Text Key: 80961299
• Report Number: 1917413-2017-00075
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981013
• 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,Followup
• Report Date: 09/25/2017

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?: No
• Device Operator: Phlebotomist
• Device Catalogue Number: 367861
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: 01/03/2017
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention