MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	369714
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter fax #: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that formation of fibrins occurred after use with a bd vacutainer® buffered sodium citrate (9 nc) blood collection tubes.The following information was provided by the initial reporter, translated from (b)(6) to english: dr.Informs of recurrences in the formation of fibrins in the 4.5 ml citrate tube (369714), in addition to the difficulties in obtaining the "minimum centrifuged" in obtaining platelets, in order to generate the minimum volume for analysis with the support (pardini), taking the recentrifugation in 03 to 04 times in average rotation of 2900 rpm.In this case, the sample indicated refers to lot 9126547, however, the dr.Informs that she always finds problems of this nature in bd tubes and does not find the same problems in vacuette tubes.
Event or Problem Description
It was reported that formation of fibrins occurred after use with a bd vacutainer® buffered sodium citrate (9nc) blood collection tubes.The following information was provided by the initial reporter, translated from portuguese to english: dr.Informs of recurrences in the formation of fibrins in the 4.5ml citrate tube (369714), in addition to the difficulties in obtaining the "minimum centrifuged" in obtaining platelets, in order to generate the minimum volume for analysis with the support (pardini), taking the re centrifugation in 03 to 04 times in average rotation of 2900rpm.In this case, the sample indicated refers to lot 9126547, however, the dr.Informs that she always finds problems of this nature in bd tubes and does not find the same problems in vacuete tubes.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for the investigation.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to fibrin were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure, fibrin, because the defect was not evident in the testing of the customer lot samples.Testing of both retain and control samples was acceptable.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) 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: 10414613
• Report Number: 1917413-2020-00708
• Device Sequence Number: 2809145
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 369714
• Device Catalogue Number: 369714
• Device Lot Number: 9126547
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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