MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD Q-SYTE¿; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Partial Blockage (1065)

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

Event Date 06/20/2022

Event Type  malfunction  

Event Description

It was reported that the unspecified bd q-syte¿ had flow issues during the infusion.The following information was provided by the initial reporter, translated from chinese: "the patient was admitted for treatment of gastroenteritis.On (b)(6) 2022, the patient was given intravenous infusion with a needle-free, closed infusion connector of a separate diaphragm.After connecting the infusion set, the fluid could not be drip-fed into the indwelling needle smoothly.".

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.Medical device expiration date: unknown.Initial reporter e-mail: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no material number, sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the unspecified bd q-syte¿ had flow issues during the infusion.The following information was provided by the initial reporter, translated from chinese: "the patient was admitted for treatment of gastroenteritis.On june 22, 2022, the patient was given intravenous infusion with a needle-free, closed infusion connector of a separate diaphragm.After connecting the infusion set, the fluid could not be drip-fed into the indwelling needle smoothly.".

Manufacturer Narrative

H.6.Investigation summary: bd was unable to perform a thorough investigation as no material number, sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: UNSPECIFIED BD Q-SYTE¿
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15433157
• MDR Text Key: 306317879
• Report Number: 2243072-2022-01524
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/27/2022
• 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