MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ 25CM EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 01/30/2023

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 franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.The reported lot# ta220740 could not be matched to any corresponding material# that fit the customer's event description.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.

Event Description

It was reported that the unspecified bd¿ 25cm extension set cracked while injecting contrast medium and leaked.These events occurred with 2 different sets.The following information was provided by the initial reporter, translated from french: "the connector cracks during the injection of contrast medium during a ct scan.This event occurred with different patients.Conservative measures and actions taken: the device was changed, the new one also cracked.A new venous line had to be placed in the patient.Each time, the leaked contrast medium had to be cleaned, which led to a disorganization of the schedule and a delay in the management of the following patients.".

Manufacturer Narrative

H6: investigation summary a di-25-g product was not available for investigation of this feedback, however the customer indicates that leakage occurred during injection of contrast fluid.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot ta220740 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Furthermore they performed functional testing of the retained samples with no leakage observed throughout testing.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported fault.However, from the information provided it appears that the damage reported by the customer was identified during injection of contrast; please note the di-25-g set is validated to withstand maximum pressures of 2 bar, if the product is subjected to pressures in excess of 2 bar, such as during injection of contrast fluid, it is possible for the product to become damaged.

Event Description

It was reported that the unspecified bd¿ 25cm extension set cracked while injecting contrast medium and leaked.These events occurred with 2 different sets.The following information was provided by the initial reporter, translated from french: "the connector cracks during the injection of contrast medium during a ct scan.This event occurred with different patients.Conservative measures and actions taken: the device was changed, the new one also cracked.A new venous line had to be placed in the patient.Each time, the leaked contrast medium had to be cleaned, which led to a disorganization of the schedule and a delay in the management of the following patients.".

• Brand Name: UNSPECIFIED BD¿ 25CM EXTENSION 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: 16432855
• MDR Text Key: 310370426
• Report Number: 2243072-2023-00255
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/13/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/23/2023
• 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