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

Catalog Number UNKNOWN

Device Problem Improper Flow or Infusion (2954)

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

Event Date 02/24/2023

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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.E.4.: the initial reporter also notified the fda on 06mar2023 medwatch report # mw511558.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using unspecified bd intravascular administration set the tubing was defective.There was no report of patient impact.The following information was provided by the initial reporter: jloop alarming throughout the day using low dose pitocin.Changed out and given to manager.The pump was alarming all day when only a small amount of fluid was infusing.Once the rate got higher, the alarming stopped.Treatment was not disrupted thanks to the nurses troubleshooting.

Event Description

It was reported while using unspecified bd intravascular administration set the tubing was defective.There was no report of patient impact.The following information was provided by the initial reporter: jloop alarming throughout the day using low dose pitocin.Changed out and given to manager.The pump was alarming all day when only a small amount of fluid was infusing.Once the rate got higher, the alarming stopped.Treatment was not disrupted thanks to the nurses troubleshooting.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 22089463.D4: medical device expiration date: 25aug2025.H4: device manufacture date: 25aug2022.D4: medical device lot #: 22089464.D4: medical device expiration date: 26aug2025.H4: device manufacture date: 26aug2022.D10: device available for eval yes, d10: returned to manufacturer on: 10-apr-2023.H6: investigation summary: one sample was received for quality investigation.The customer complaint of tubing defective/damaged could not be verified by inspection of the sample received.The sample extension set was connected to a sample primary infusion set and primed using water with blue color dye.The extension set primed without any issues.The extension set was then connected to a sample picc line on the outlet male connector to see if the connectors were leaking at their joints.There were no leaks at any of the extension set connectors.A simulated infusion was then conducted with the pumping rate at 200 ml/hr and a dispensing volume of 50 ml to determine if the extension set was creating a slow infusion rate or causing an occlusion issue during an infusion.There were no occlusions during the infusion period and the volume dispensed was the correct amount.No further issues were identified during the testing of the sample.The material number and lot number of the sample was reported as unknown.The following device history review was conducted based on the material number and lot number determined by reviewing the production data of the maxzero connector on the sample submitted by the customer.A device history record review for model mzx5302 lot number 22089463 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 mzx5302 lot number 22089464 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined because the reported failure could not be replicated.

• Brand Name: UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION 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 ; 8448235433
• MDR Report Key: 16740456
• MDR Text Key: 313714128
• Report Number: 2243072-2023-00612
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/16/2023
• 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