MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366664
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.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.Device manufacture date: unknown.
Event or Problem Description
Material no.366664, batch no.Unknown.It was reported that during use of the bd vacutainer® lithium heparinn (lh) 37 usp units blood collection tubes the tubes are under filling.The following information was provided by the initial reporter: it has come to our attention that one of our sites is having substantial problems with the soft draw tubes.They are reporting underfilling (only 2/3 full) including the green and lavender.This is mostly a problem when using a butterfly.The site confirmed that they are using the clear discard tube to clear the butterfly tubing first and then the flow stops once the soft draw tubes are attached.We are looking into the type of adapter they are using for the tubes to see if this could be the reason.
Additional Manufacturer Narrative
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 a capa 260774.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.H3 other text : see section h.10.
Event or Problem Description
Material no.366664.Batch no.Unknown.It was reported that during use of the bd vacutainer® lithium heparinn (lh) 37 usp units blood collection tubes the tubes are under filling.The following information was provided by the initial reporter: it has come to our attention that one of our sites is having substantial problems with the soft draw tubes.They are reporting underfilling (only 2/3 full) including the green and lavender.This is mostly a problem when using a butterfly.The site confirmed that they are using the clear discard tube to clear the butterfly tubing first and then the flow stops once the soft draw tubes are attached.We are looking into the type of adapter they are using for the tubes to see if this could be the reason.

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN (LH) 37 USP UNITS 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: 9076372
• Report Number: 1917413-2019-02084
• Device Sequence Number: 449238
• Product Code: JKA
• UDI-Device Identifier: 50382903666640
• UDI-Public: 50382903666640
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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 Catalogue Number: 366664
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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