MAUDE Adverse Event Report: MICROBORE EXTENSION SET, IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9277
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.Initial reporter facility: (b)(6).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 microbore extension set, iv connector had air bubbles.The following information was provided by the initial reporter: see feedback below.Hard to draw blood, lots of resistance & hemolyzed samples.When drawing blood, air also being drawn in (bubbles in line) - tubes not filling - qns from lab on blue tops.Need to use syringes to draw blood (can't use vacutainer) & then need transfer device or needle to transfer blood - not as safe! fluid boluses per gravity do not drip! need to use pump tubing for fluids.Only able to infuse 1 l at a time using pump - lots of resistance to fluid bolus & repeat alarms.
Event or Problem Description
It was reported that microbore extension set, iv connector experienced air bubbles and hemolysis.The following information was provided by the initial reporter: see feedback below ¿ hard to draw blood, lots of resistance & hemolyzed samples.When drawing blood, air also being drawn in (bubbles in line) - tubes not filling - qns from lab on blue tops.Need to use syringes to draw blood (can't use vacutainer) & then need transfer device or needle to transfer blood - not as safe! fluid boluses per gravity do not drip! need to use pump tubing for fluids.Only able to infuse 1 l at a time using pump - lots of resistance to fluid bolus & repeat alarms.
Additional Manufacturer Narrative
Correction: after further review, an additional failure mode was determined.The following information has been updated: b.5.Describe event or problem: it was reported that microbore extension set, iv connector experienced air bubbles and hemolysis.H.6.Imdrf annex a grid: a140502, a0908.Investigation: h.6 investigation summary: the three photos taken by the customer do not confirm the failure mode of air bubbles / air in line.No product was returned by the customer.The customer complaint that this weekend, there multiple issues with the new bd maxzero microbore extension set (ref mz9277) could not be verified due to the product not being returned for failure investigation.A device history record review for model mz9277 lot number 21025647 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23feb2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12329002
• Report Number: 9616066-2021-51791
• Device Sequence Number: 17255101
• Product Code: FPA
• UDI-Device Identifier: 10885403240799
• UDI-Public: 10885403240799
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/14/2021

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 Catalogue Number: MZ9277
• Device Lot Number: 21025647
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1