MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 393242

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported that 61 bd venflon¿ pro safety shielded iv catheters' blister packs were discolored.The following information was provided by the initial reporter: "cannula packing is damaged.".

Manufacturer Narrative

Investigation summary: two photos were received by our quality team for evaluation.From the photos, a 22g unit pack and a 22g unit pack with top web product information was observed.The unit pack appears to be deformed; however, the details cannot be seen clearly from the photos.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The manufacturing process was reviewed.There is no process in the manufacturing process that would cause the reported defect.There were no abnormalities during the production of the reported batch.Therefore, the reported defect could have occurred out of the manufacturing facility.The probable root cause for the deformed package could be due to the product being exposed to heat during handling (transportation, storage, loading and unloading, etc).This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13065264
• MDR Text Key: 285405655
• Report Number: 8041187-2021-01071
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393242
• Device Lot Number: 1203944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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