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

Model Number	381244
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8234059.Medical device expiration date: 2023-08-31.Device manufacture date: 2018-08-22.Medical device lot #: 9014978.Medical device expiration date: 2023-12-31.Device manufacture date: 2019-01-14.Medical device lot #: 9054551.Medical device expiration date: 2024-02-28.Device manufacture date: 2019-02-23.The reported lot # [8082178] was not found for the reported catalog # [381244].A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that an "extra piece of plastic" was found on the bd insyte¿ iv catheter before inserting it into the patient, and it "came off when touched".Lot#'s 8234059, 9014978, 8082178, and 9054551 were reported to have been involved in this event, each with 2 occurrences of the event.The following information was provided by the initial reporter: one of our doctors noticed on x2 cases that as he was about to insert a 18g jelco that there was an extra piece of plastic on the outside of the jelco.The plastic came off when touched.I think it is a high risk of going unnoticed and potentially being inserted into patient.
Event or Problem Description
It was reported that an "extra piece of plastic" was found on the bd insyte¿ iv catheter before inserting it into the patient, and it "came off when touched".Lot#'s 8234059, 9014978, 8082178, and 9054551 were reported to have been involved in this event, each with (b)(4) occurrences of the event.The following information was provided by the initial reporter: one of our doctors noticed on x2 cases that as he was about to insert a 18g jelco that there was an extra piece of plastic on the outside of the jelco.The plastic came off when touched.I think it is a high risk of going unnoticed and potentially being inserted into patient.
Additional Manufacturer Narrative
H.6.Investigation summary one photo was received by our quality team for evaluation.Upon visual inspection, a transparent like foreign matter was observed to be on the catheter; therefore, the incident could be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Since a sample was not received no further investigation could be conducted; therefore, a root cause could not be determined.The complaint will be reopened if a sample is received.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

• Brand Name: BD INSYTE¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9844759
• Report Number: 8041187-2020-00153
• Device Sequence Number: 2377929
• Product Code: FOZ
• UDI-Device Identifier: 30382903812449
• UDI-Public: 30382903812449
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 381244
• Device Catalogue Number: 381244
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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