MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	369714
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the stopper pops off during use with an bd vacutainer® buffered sodium citrate (9nc) blood collection tubes.The following information was provided by the initial reporter: (3 of 3 complaints) the nurse indicated that once blood specimen collection was complete and as she was labeling the specimens the cap/lid spontaneously blew off.Blood all over the table.Additionally, on 2020-06-29 the bd sales consultant provided the following additional information: did the course of treatment change? yes¿ the patient had to be poked again.Was there any exposure to blood/bodily fluids due to the stopper popping off? blood spewed all over the nursing station desk.Was there any medical attention needed? for example lab testing or administration of antivirals? no.Was a holder used? was it a bd holder? all products used are bd.Was the acquisition device bd? not sure what you mean by an acquisition device¿? what is the acquisition device that was used? never heard a product described as an acquisition device¿.Do you mean a venipuncture device? was a syringe used to fill tubes? was plunger pushed to blood or was the vacuum used to draw the blood into the tube? no syringes no plungers¿ just the vacuum of the vacutainer tube.Was the closure recapped? was there a tight seal? nothing re-capped.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/13/2020.H.6.Investigation: bd received 4 samples from the customer for investigation.All samples were evaluated by visual examination and functional testing and the indicated failure mode for stopper pop off with the incident lot was not observed.Additionally, 10 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to the indicated failure mode as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.
Event or Problem Description
It was reported that the stopper pops off during use with an bd vacutainer® buffered sodium citrate (9nc) blood collection tubes.The following information was provided by the initial reporter: (3 of 3 complaints) the nurse indicated that once blood specimen collection was complete and as she was labeling the specimens the cap/lid spontaneously blew off.Blood all over the table.Additionally, on 2020-06-29 the bd sales consultant provided the following additional information: · did the course of treatment change? yes¿ the patient had to be poked again · was there any exposure to blood/bodily fluids due to the stopper popping off? blood spewed all over the nursing station desk.O was there any medical attention needed? for example lab testing or administration of antivirals? no.· was a holder used? was it a bd holder? all products used are bd.· was the acquisition device bd? not sure what you mean by an acquisition device¿? · what is the acquisition device that was used? never heard a product described as an acquisition device¿.Do you mean a venipuncture device? · was a syringe used to fill tubes? was plunger pushed to blood or was the vacuum used to draw the blood into the tube? no syringes no plungers¿ just the vacuum of the vacutainer tube.· was the closure recapped? was there a tight seal? nothing re-capped.

• Brand Name: BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10258549
• Report Number: 1917413-2020-00573
• Device Sequence Number: 10883784
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/03/2020

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: 04/30/2021
• Device Model Number: 369714
• Device Catalogue Number: 369714
• Device Lot Number: 9280966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/03/2020
• 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