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

Model Number	381334
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte¿ iv catheter packaging was not completely sealed.This was discovered before use.The following information was provided by the initial reporter: the packaging is often completely sealed which makes it impossible to open it sterile.For the time being, only this lot is in stock in the warehouse and it is not possible to check whether other lots are involved.
Additional Manufacturer Narrative
H.6.Investigation: five representative samples were received by our quality team for evaluation.Upon visual inspection, the adhesive was observed on the bottom web indicating slitting misalignment which result in difficulty to open the packaging; therefore, the incident could be verified.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 investigation, the packaging being completely sealed could have occurred due to the misalignment of the blade during the slitting process.A review of the manufacturing process shows that the screw nut which is used to secure the cutter support came loose due to vibration while the machine is running.
Event or Problem Description
It was reported that bd insyte¿ iv catheter packaging was not completely sealed.This was discovered before use.The following information was provided by the initial reporter: the packaging is often completely sealed which makes it impossible to open it sterile.For the time being, only this lot is in stock in the warehouse and it is not possible to check whether other lots are involved.

• 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: 9819052
• Report Number: 8041187-2020-00137
• Device Sequence Number: 2818541
• Product Code: FOZ
• UDI-Device Identifier: 30382903813347
• UDI-Public: 30382903813347
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/03/2020

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: Other
• Device Expiration Date: 10/31/2024
• Device Model Number: 381334
• Device Catalogue Number: 381334
• Device Lot Number: 9308160
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/03/2020
• 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