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

Model Number	366480
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/28/2020
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.
Event or Problem Description
It was reported that damage / defects / foreign matter were found before use with bd vacutainer® sodium heparin (nh) blood collection tubes.The following information was provided by the initial reporter, "we have discovered a batch of heparin tubes that had a number of manufacturing defects.Date of awareness: 28 april 2020.Defects: cracked glass cane (one tube).Stopper deformation (one tube).Stopper deformation with embedded foreign matter (one tube)." 4 occurrences were reported.
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 fm on the stopper, defective stopper molding and defective glass forming with the incident lot was observed.Additionally, evaluation of the customer samples was performed and fm on the stopper, defective stopper molding and defective glass forming was 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.H3 other text : see h.10.
Event or Problem Description
It was reported that damage / defects / foreign matter were found before use with bd vacutainer® sodium heparin¿ (nh) blood collection tubes.The following information was provided by the initial reporter, "we have discovered a batch of heparin tubes that had a number of manufacturing defects.Date of awareness: (b)(6) 2020 defects: cracked glass cane (one tube); stopper deformation (one tube); stopper deformation with embedded foreign matter (one tube)".4 occurrences were reported.

• Brand Name: BD VACUTAINER SODIUM HEPARIN (NH) 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: 10061835
• Report Number: 1917413-2020-00440
• Device Sequence Number: 3753286
• Product Code: JKA
• UDI-Device Identifier: 50382903664806
• UDI-Public: 50382903664806
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

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: Other
• Device Expiration Date: 02/28/2021
• Device Model Number: 366480
• Device Catalogue Number: 366480
• Device Lot Number: 9036725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 06/09/2020
• 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