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

Catalog Number	381254
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 the bd insyte¿ iv catheter packaging had "no adhesion" and opened easily.
Additional Manufacturer Narrative
Investigation summary: 2 actual unused samples were returned for investigation.The sample was not decontaminated.The sample was observed not sealed at the top of the packaging.Sample evaluation: the samples were subjected to visual examination and observe that the top of the packaging was not sealed (open seal).There is an indication of adhesive transferred from the top web to the bottom web on the opened seal area and thus showed that the sealing process was completed in the manufacturing facility.Indication of adhesive transfer to bottom web the investigation was able to confirm the customer experience based on the sample evaluation.There is an indication of adhesive transferred from the top web to the bottom web on the opened seal area and thus showed that the sealing process was completed in the manufacturing facility.Hence, no assignable root cause.There was a change in the top web material during jul 2017.The reported batch was produced before the material change.
Event or Problem Description
It was reported that the bd insyte¿ iv catheter packaging had "no adhesion" and opened easily.

• 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: 8179088
• Report Number: 8041187-2018-00482
• Device Sequence Number: 1406872
• Product Code: FOZ
• UDI-Device Identifier: 30382903812548
• UDI-Public: 30382903812548
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 02/05/2019

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: 04/30/2021
• Device Catalogue Number: 381254
• Device Lot Number: 6113171
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/06/2019
• 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