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	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the case of material # 366664 bd vacutainer® lithium heparin (lh) 37 usp units blood collection tubes had a material # 367983 labeled tube in it found before use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "i found an case that had a different item in it." the customer received incorrect material - not on po & material packed was not per label.Labeled 367983 - packed 366664 - this is not claims related.
Additional Manufacturer Narrative
H.6.Investigation: bd did not receive samples, but photos were provided for investigation.The photos were evaluated and it was found that the reported incident lots are manufactured at two different sites, therefore there is no potential for a mix-up of the products occurring at the plant level.Furthermore, the distribution center only receives and ships these materials in full carton cases ((b)(4) pcs); and does not perform any repackaging.The sales order associated to the obtained po from a provided photo was reviewed and neither a lithium heparin nor an sst carton case was included within the crate.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that the case of material # 366664 bd vacutainer® lithium heparinn (lh) 37 usp units blood collection tubes had a material # 367983 labeled tube in it found before use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "i found an case that had a different item in it." the customer received incorrect material - not on po & material packed was not per label.Labeled 367983, packed 366664.This is not claims related.

• 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: 8713403
• Report Number: 1917413-2019-01608
• Device Sequence Number: 1729878
• Product Code: JKA
• UDI-Device Identifier: 50382903666640
• UDI-Public: 50382903666640
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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 Expiration Date: 03/31/2020
• Device Catalogue Number: 366664
• Device Lot Number: 8303628
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 09/16/2019
• 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