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 Code	Short Fill (1575)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 8249993.Medical device expiration date: 2020-01-31.Device manufacture date: 2018-09-06.Medical device lot #: 9065767.Medical device expiration date: 2020-07-31.Device manufacture date: 2019-03-06.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd vacutainer® lithium heparinn (lh) 37 usp units blood collection tubes are underfilling.This was discovered during use.The following information was provided by the initial reporter: (b)(4) ,batch no: unknown (possible 8249993, 9065767).It was reported the tubes are underfilling.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.
Event or Problem Description
It was reported that bd vacutainer® lithium heparinn (lh) 37 usp units blood collection tubes are underfilling.This was discovered during use.The following information was provided by the initial reporter: (b)(4).Batch no: unknown (possible 8249993, 9065767).It was reported the tubes are underfilling.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 received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for underfill with the incident lot was observed.However, evaluation/testing of the customer samples was performed and underfill was not observed.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.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.H3 other text.

• 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: 8967180
• Report Number: 1917413-2019-02020
• Device Sequence Number: 3295269
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: Other
• Device Catalogue Number: 366664
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/20/2019
• 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