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

Catalog Number UNKNOWN

Device Problem Volume Accuracy Problem (1675)

Patient Problem Insufficient Information (4580)

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(6) has been listed in sections d.3.And g.1.And the (b)(6) fda registration number has been used for the manufacture report number.B3.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown.

Event Description

It was reported that bd unspecified bd infusion set had a issue with volume accuracy.The following information was provided by the initial reporter with the verbatim: ¿the nicu staff at doctor's (b)(6) hospital discovered that the 12 ml monoject syringes used to administer medications to the nicu patient, left approximately 0.5 ml in the syringe after the programmed infusion.Per the nicu director this only occurred with monoject not the bd 12ml syringe.This was brought to the hospital's pharmacy and central supply departments attention and after investigation they found that the monoject 12ml and 3ml had two different manufacturers, covidien and cardinal.Moreover, the aforementioned departments found visible discrepancies with the covidien and cardinal monoject syringes.The cardinal 3ml & 12ml syringes were longer and more narrow than the covidien, which was shorter and wider.It is unknown which syringe was leaving the approximate 0.5ml of medication as once the syringe in removed from the package for preparation by pharmacy there are no identifiable cardinal or covidien markings.Per the supply chain operations director, xxxxxx xxxxx , uhs corporate is aware of this.¿.

Event Description

It was reported that bd unspecified bd infusion set had a issue with volume accuracy.The following information was provided by the initial reporter with the verbatim: ¿the nicu staff at doctor's hospital of laredo discovered that the 12 ml monoject syringes used to administer medications to the nicu patient, left approximately 0.5 ml in the syringe after the programmed infusion.Per the nicu director this only occurred with monoject not the bd 12ml syringe.This was brought to the hospital's pharmacy and central supply departments attention and after investigation they found that the monoject 12ml and 3ml had two different manufacturers, covidien and cardinal.Moreover, the aforementioned departments found visible discrepancies with the covidien and cardinal monoject syringes.The cardinal 3ml & 12ml syringes were longer and more narrow than the covidien, which was shorter and wider.It is unknown which syringe was leaving the approximate 0.5ml of medication as once the syringe in removed from the package for preparation by pharmacy there are no identifiable cardinal or covidien markings.Per the supply chain operations director, xxxxxx xxxxx , uhs corporate is aware of this.¿.

Manufacturer Narrative

Investigation summary a complaint of syringe volume being inaccurate was received from the customer.No product or photo was returned by the customer.The customer complaint of volume accuracy could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot and model number are unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: UNSPECIFIED BD INFUSION 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): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17703486
• MDR Text Key: 322891170
• Report Number: 2243072-2023-01591
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• 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