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

Catalog Number UNKNOWN

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluation: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.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)(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.

Event Description

It was reported that the unspecified bd infusion set experienced over-infusion with the secondary medication.The following information was provided by the initial reporter: it was a reported over-infusion with a secondary medication.Clinical staff were able to confirm based on the colour of the primary fluid that back-flow of secondary into the primary did not occur.

Manufacturer Narrative

The following fields were updated due possible lots: d4: medical device lot #: 22075907.D4: medical device expiration date: 02aug2025.H4: device manufacture date: 02aug2022.D4: medical device lot #: 22076014.D4: medical device expiration date: 03aug2025.H4: device manufacture date: 03aug2022.D4: medical device lot #: 22085032.D4: medical device expiration date: 03aug2025.H4: device manufacture date: 03aug2022.D4: medical device lot #: 22085073.D4: medical device expiration date: 10aug2025.H4: device manufacture date: 10aug2022.D4: medical device lot #: 22085074.D4: medical device expiration date: 11aug2025.H4: device manufacture date: 11aug2022.D4: medical device lot #: 22085416.D4: medical device expiration date: 10aug2025.H4: device manufacture date: 10aug2022.D4: medical device lot #: 22085436.D4: medical device expiration date: 11aug2025.H4: device manufacture date: 11aug2022.D4: medical device lot #: 22085438.D4: medical device expiration date: 10aug2025.H4: device manufacture date: 10aug2022 the following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: h6: investigation summary it was observed during functional testing on returned set model 2420-0007 lot unknown that a backflow was observed.A quality notification was sent to the supplier, and the failed back check valve was sent for further investigation.For the supplier investigation, particulate presence could not be confirmed.The check valve was inspected for backflow on bench testers and backflow failure was not observed.Given the findings, the supplier is unable to confirm the reported failure mode of backflow and will close with no further actions.The root cause was unable to be determined.A lot is unknown, however, possible lots were identified to be: 22075907, 22076014, 22085032, 22085073, 22085074, 22085416, 22085436, 22085438.A device history record review for model 2420-0007 lot number 22075907 was performed.There was a quality notification issued for the failure mode reported by the customer during the production build of this set for the lot 22075907 as notification id #200335547 on 04aug2022.A device history record review for model 2420-0007 lot number 22076014 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 lot number 22085032 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 lot number 22085073 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 lot number 22085074 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 lot number 22085416 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 lot number 22085436 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0007 lot number 22085438 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.

Event Description

It was reported that the unspecified bd infusion set experienced over-infusion with the secondary medication.The following information was provided by the initial reporter: it was a reported over-infusion with a secondary medication.Clinical staff were able to confirm based on the colour of the primary fluid that back-flow of secondary into the primary did not occur.

• Brand Name: UNSPECIFIED BD INFUSION SET
• 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: 16081860
• MDR Text Key: 308569189
• Report Number: 2243072-2022-02261
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/17/2023

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: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/02/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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