MAUDE Adverse Event Report: BECTON DICKINSON SAFETY LOK INFUSION SET WITH FILTER; INTRAVASCULAR CATHETER

Model Number	47260025
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248); Leak/Splash (1354)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A 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)(4) has been listed, and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the safety lok infusion set with filter program "froze" and became nonfunctional, causing hypotension, and a delay in treatment to the patient.The following information was provided by the initial reporter: "e2321 - low blood pressure/hypotension f23 - unexpected medical intervention f05 - delay to treatment/therapy a110201 - application program freezes, becomes nonfunctional.".
Additional Manufacturer Narrative
Correction: the failure mode reported is not applicable to the infusion set model provided by the customer, as "application freezes and becomes nonfunctional¿ refers to a computer-related product.As additional information was not received for this complaint, it will be reported as the disposable.The following information has been updated: b.3.Date of event: unknown.The date received by manufacturer has been used for this field.B.3.Date of event: (b)(6) 2020.B.5.Describe event or problem: it was reported that the safety lok infusion set with filter tubing was defective and as the unspecified infusion set program "froze" and became nonfunctional.C.2.Concomitant med prod data: unspecified bd¿ infusion set f.10.Device codes: 1354 g.4.Date received by manufacturer: 2020-09-17 investigation: h.6.Investigation summary: no product or photo was returned by the customer.A device history record review could not be performed on model 47260025 because a lot number was not provided by the customer.Investigation conclusion: the customer complaint that the application freezes and becomes nonfunctional could not be verified due to the product not being returned for failure investigation.Root cause description: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Rationale: per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.
Event or Problem Description
It was reported that the safety lok infusion set with filter tubing was defective and as the unspecified infusion set program "froze" and became nonfunctional.The following information was provided by the initial reporter: "e2321 - low blood pressure/hypotensionf23 - unexpected medical interventionf05 - delay to treatment/therapy a110201 - application program freezes, becomes nonfunctional".

• Brand Name: SAFETY LOK INFUSION SET WITH FILTER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10659359
• Report Number: 2243072-2020-01624
• Device Sequence Number: 11549676
• Product Code: FPA
• UDI-Device Identifier: 00382904726003
• UDI-Public: (01)00382904726003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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 Model Number: 47260025
• Device Catalogue Number: 47260025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 01/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED BD¿ INFUSION SET
• Outcome Attributed to Adverse Event: Other