MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXTENSION SET MICROBORE SLIDE CLAMP(S); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 30910

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/25/2023

Event Type  Injury  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the bd extension set microbore slide clamp(s) experienced adverse event without identified device.The following information was provided by the initial reporter: we have had significant clinical issues with the bd 30910 microbore extension set(36in, 0.4ml) it is insufficient for our clinical needs and has caused critical incidents due to cessation of vasopressors and surgical anesthetics.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 18-jul-2023.H6: investigation summary two hundred samples of material number 30910, lot 211090149 were received for quality investigation.The customer dissatisfaction of the product could not be verified or confirmed due to the lack of description of the failures being reported.The samples submitted were still in their packaging and there were no signs of any problems with the products.A root cause could not be determined because a specific failure was not identified.

Event Description

It was reported that the bd extension set microbore slide clamp(s) experienced adverse event without identified device.The following information was provided by the initial reporter: we have had significant clinical issues with the bd 30910 microbore extension set(36in, 0.4ml) it is insufficient for our clinical needs and has caused critical incidents due to cessation of vasopressors and surgical anesthetics.".

• Brand Name: BD EXTENSION SET MICROBORE SLIDE CLAMP(S)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17269730
• MDR Text Key: 318497361
• Report Number: 9616066-2023-01364
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

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?: No
• Device Operator: Other
• Device Catalogue Number: 30910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other