MAUDE Adverse Event Report: BECTON DICKINSON BD¿ GRAVITY PUMP INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 03500113321

Device Problem Fitting Problem (2183)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

It was reported that the bd¿ gravity pump infusion set distal cap did not fit over the end of the tip and rendered it unsterile.The following information was provided by the initial reporter, translated from french: "when the pack is opened, the distal cap does not fit over the end of the kit and the end is no longer sterile.The head nurse of the hbw intensive care unit informs me that when the pack is opened the distal cap does not fit on the end of the kit.Batch 2020 05 20, all packs affected, the tip is no longer sterile.".

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is hanscent.This site is an oem manufacturing site.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.The reported lot# 20200520 was not found for the reported catalog# 03500113321.Medical device expiration date: unknown.Device evaluated by mfr: 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.

Manufacturer Narrative

H6: investigation summary: a 03500113321hn product was not available for investigation; however the customer confirmed that the complaint sample was from lot 20200520.From the information provided by the customer it appears that the male luer cap could not be placed onto the male luer of the infusion set; however no additional information was available to assist the investigation.The details of this feedback were forwarded to the legal manufacturer, anhui tiankang medical products co.,ltd, for investigation.A review of the production records from lot 20200520 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.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 customer¿s experience.

Event Description

It was reported that the bd¿ gravity pump infusion set distal cap did not fit over the end of the tip and rendered it unsterile.The following information was provided by the initial reporter, translated from french: "when the pack is opened, the distal cap does not fit over the end of the kit and the end is no longer sterile.The head nurse of the hbw intensive care unit informs me that when the pack is opened the distal cap does not fit on the end of the kit.Batch 2020 05 20, all packs affected, the tip is no longer sterile.".

• Brand Name: BD¿ GRAVITY PUMP 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: 16261493
• MDR Text Key: 308445850
• Report Number: 2243072-2023-00086
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• 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: 02/16/2023

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: Health Professional
• Device Catalogue Number: 03500113321
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/28/2023
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 03/08/2023
• 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