MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNSPECIFIED BD MAXZERO¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no samples were received for investigation of complaint reported via post market survey; however the customer has indicated that a leakage was identified during use of a bd maxzero¿ needle-free connector.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.In this instance, without the complaint sample or additional information about the exact nature of the defect it is not possible to conclusively link this feedback to a specific failure mode.

Event Description

It was reported that 14 unspecified bd maxzero¿ extension sets leaked nacl, g5, psl, and antibiotics, 6 sets were occluded, 2 sets had poor tubing clamp attachment after clipping them, 1 set leaked fluid, and 2 sets had slow flow issues.The following information was provided by the initial reporter: "it was reported via post market survey that clinicians encountered leakage of fluids (not contrast media and not during power injection) (14) , obstruction (6) , clamp (2) ,leakage of fluid (1) and bottleneck effect (2)." "additional information related to the fluid(s) that leaked when using the bd maxzero¿ extension set(s) (not during power injection).Nacl, g5, psl, and antibiotic." "obstruction in the catheter, poor clamp attachment when clipping, and "when used for the first time, it is difficult to drain despite the safety device being removed.".

Manufacturer Narrative

H6: investigation summary: no samples were received for investigation of complaint reported via post market survey; however: the customer has indicated that a leakage was identified during use of an unknown bd maxzero¿ extension set.The customer has indicated that flow restriction is encountered on first use of an unknown bd maxzero¿ extension set.The customer has indicated that issues were faced with the clamp of an unknown bd maxzero¿ extension set.The customer has indicated that an occlusion was identified during use of an unknown bd maxzero¿ extension set.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.H3 other text : see h10.

Event Description

It was reported that 14 unspecified bd maxzero¿ extension sets leaked nacl, g5, psl, and antibiotics, 6 sets were occluded, 2 sets had poor tubing clamp attachment after clipping them, 1 set leaked fluid, and 2 sets had slow flow issues.The following information was provided by the initial reporter: "it was reported via post market survey that clinicians encountered leakage of fluids (not contrast media and not during power injection) (14) , obstruction (6) , clamp (2) ,leakage of fluid (1) and bottleneck effect (2)"."additional information related to the fluid(s) that leaked when using the bd maxzero¿ extension set(s) (not during power injection).Nacl, g5, psl, and antibiotic"."obstruction in the catheter, poor clamp attachment when clipping, and "when used for the first time, it is difficult to drain despite the safety device being removed."".

• Brand Name: UNSPECIFIED BD MAXZERO¿ EXTENSION SET
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12636644
• MDR Text Key: 276599134
• Report Number: 9616066-2021-52236
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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