MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-N IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381311
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 insyte-n¿ iv catheter tip was damaged and leaked.This occurred 5 different times during use.The following information was provided by the initial reporter, "at the time of insertion of the catheter into the vein there was a leak from the side (the space between the needle and the catheter) and the back chamber did not fill with blood.Also, the tip of the catheter was damaged (i.E.The transparent silicone was shorter than the needle itself).The customer using the insyte -w (381312), by mistake they received the insyte-n (381311), so in their carts they had both of them.They claim the leak happened from both products.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/21/2020 h.6.Investigation: two representative samples were received by our quality team for evaluation.These samples were subjected to visual inspection and catheter leak test.No catheter damage was observed on the returned samples.The investigation was not able to confirm what the catheter had experienced as no abnormalities were observed.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.See h.10.
Event or Problem Description
It was reported that the bd insyte-n¿ iv catheter tip was damaged and leaked.This occurred 5 different times during use.The following information was provided by the initial reporter: "at the time of insertion of the catheter into the vein there was a leak from the side (the space between the needle and the catheter) and the back chamber did not fill with blood.Also, the tip of the catheter was damaged (i.E.The transparent silicone was shorter than the needle itself) the customer using the insyte -w (381312), by mistake they received the insyte-n (381311) - so in their carts they had both of them.They claim the leak happened from both products.".

• Brand Name: BD INSYTE-N IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10668543
• Report Number: 8041187-2020-00672
• Device Sequence Number: 19704451
• Product Code: FOZ
• UDI-Device Identifier: 30382903813118
• UDI-Public: 30382903813118
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K151698
• 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): 12/02/2020

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: Other
• Device Expiration Date: 07/31/2024
• Device Model Number: 381311
• Device Catalogue Number: 381311
• Device Lot Number: 9203377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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