MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER WITH WINGS; INTRAVASCULAR CATHETER

Model Number	386821
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter with wings was damaged and detached from the needle too easily during use.The following information was provided by the initial reporter, translated from french to english: "during the first attempt to insert a cathlon (24g), it is impossible to guide the cathlon because it dissociates too easily from the needle, forced to keep the cathlon proximal, therefore lack of asepsis.Moreover, the cathlon is too flexible and therefore cannot be held in the vein.At the second attempt, blood return was present but after fixation the diffuse venous route was present.In the third attempt, with a 22g cathlon, the needle and the cathlon dissociated as soon as it was introduced subcutaneously and could not be guided: the insertion failed.Conclusion: 3 unsuccessful insertion attempts due to defective or poor quality material.The venous route was from the first attempt with another type of cathlon." "clinical consequences: child on meopa for a long period of time which ended in vomiting.".
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter with wings was damaged and detached from the needle too easily during use.The following information was provided by the initial reporter, translated from french to english: "during the first attempt to insert a cathlon (24g), it is impossible to guide the cathlon because it dissociates too easily from the needle, forced to keep the cathlon proximal, therefore lack of asepsis.Moreover, the cathlon is too flexible and therefore cannot be held in the vein.At the second attempt, blood return was present but after fixation the diffuse venous route was present.In the third attempt, with a 22g cathlon, the needle and the cathlon dissociated as soon as it was introduced subcutaneously and could not be guided: the insertion failed.Conclusion: 3 unsuccessful insertion attempts due to defective or poor quality material.The venous route was from the first attempt with another type of cathlon." "clinical consequences: child on meopa for a long period of time which ended in vomiting.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-12-22.H6: investigation summary: two photos were received by our quality team for evaluation.No catheter damage was observed on both returned samples.Therefore, the investigation was not able to confirm the customer experience.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD CATHENA SAFETY IV CATHETER WITH WINGS
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10709338
• Report Number: 8041187-2020-00680
• Device Sequence Number: 3333410
• Product Code: FOZ
• UDI-Device Identifier: 00382903868216
• UDI-Public: 00382903868216
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 386821
• Device Catalogue Number: 386821
• Device Lot Number: 9123744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 09/26/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other