MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE; BLOOD COLLECTION NEEDLE

Catalog Number	368587
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 underfill occurred during use with a bd vacutainer® precisionglide¿ multiple sample needles.The following information was provided by the initial reporter, "tube experienced under filling during use." cat# 368587.Lot# 9065849.(b)(6) 2019.(b)(6) 2019.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for underfill with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, the issue relating to 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#260774.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.
Event or Problem Description
It was reported that underfill occurred during use with a bd vacutainer® precisionglide¿ multiple sample needles.The following information was provided by the initial reporter, "tube experienced under filling during use." cat# 368587 and lot# 9065849; 29-jul-2019, 7-aug-2019.

• Brand Name: BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE
• Common Device Name: BLOOD COLLECTION NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8940436
• Report Number: 1917413-2019-01986
• Device Sequence Number: 2559633
• Product Code: JKA
• UDI-Device Identifier: 50382903685870
• UDI-Public: 50382903685870
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 07/31/2020
• Device Catalogue Number: 368587
• Device Lot Number: 9065849
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/17/2019
• 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