MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE ADAPTER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem Underdose (2542)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: 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)(4) has been listed, and (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 Description

It was reported that the unspecified bd¿ syringe adapter connected to the unspecified infusion pump under-infused during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: they believe the syringe adapters may at be fault for these under infusions.It would be great to get to the bottom of this issue, it is a critical issue with the type of infusion that we're trying to do with the new syringe adaptor for the 8100 module infusion pump.It is not just 1 pump, or 1 pc that is having this under-infusion issue.It is several.To me it sounds more about the adaptors themselves that are the problem.Many of the under-infusion tests have been run without patient involvement.

Event Description

It was reported that the unspecified bd¿ syringe adapter connected to the unspecified infusion pump underinfused during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: they believe the syringe adapters may at be fault for these under infusions.It would be great to get to the bottom of this issue, it is a critical issue with the type of infusion that we're trying to do with the new syringe adaptor for the 8100 module infusion pump.It is not just 1 pump or 1 pc that is having this underinfusion issue.It is several.To me it sounds more about the adaptors themselves that are the problem.Many of the underinfusion tests have been run without patient involvement.

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.It was reported that the syringe adapters may be at fault for under infusions.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model or lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.

• Brand Name: UNSPECIFIED BD SYRINGE ADAPTER
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10910006
• MDR Text Key: 218575440
• Report Number: 2243072-2020-01951
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• 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
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED BD¿ INFUSION PUMP