MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® ESR BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	369741
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the bd vacutainer® esr blood collection tubes had an issue with low draw.The following information was provided by the initial reporter, translated from (b)(6) to english: during use, the customer found 1ea tube has low draw issue.
Event or Problem Description
It was reported that during use of the bd vacutainer® esr blood collection tubes had an issue with low draw.The following information was provided by the initial reporter, translated from chinese to english: during use, the customer found 1ea tube has low draw issue.
Additional Manufacturer Narrative
Correction: g.1.Manufacturing location: becton, dickinson & co.(broken bow).H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.A review of the device history record was completed for the incident lot 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.Bd has initiated further investigation relating to this issue through capa 260774 and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.H3 other text : see section h.10.

• Brand Name: BD VACUTAINER® ESR BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9321535
• Report Number: 1917413-2019-02350
• Device Sequence Number: 14002487
• Product Code: JKA
• UDI-Device Identifier: 50382903697415
• UDI-Public: 50382903697415
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 369741
• Device Lot Number: 9065864
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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