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

Catalog Number	381254
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 cannula adhesive on packaging came apart.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Correction: describe event or problem: it was reported that bd insyte¿ iv cannula adhesive on packaging came apart on 4 devices.No serious injury or medical intervention was reported.Investigation summary: a device history record review showed no non-conformance's associated with this issue during the production of this batch.4 actual samples were returned for investigation.The actual samples were subjected to visual inspection.Open seal was observed on the 4 corners of both returned sample.There is an indication of adhesive transferred from the top web to the bottom web on the opened seal area, which was present on the returned samples and thus, showed that the sealing process was completed in manufacturing facility.There was change in top web material during jul 2017.The reported batch was produced before the material change.Therefore, no assignable root cause can be established.There is an indication of adhesive transferred from the top web to the bottom web on the opened seal area which showed that the sealing process was completed in manufacturing facility.
Event or Problem Description
It was reported that bd insyte¿ iv cannula adhesive on packaging came apart on 4 devices.No serious injury or medical intervention was reported.

• Brand Name: BD INSYTE¿ IV CANNULA
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8165185
• Report Number: 8041187-2018-00487
• Device Sequence Number: 19350402
• Product Code: FOZ
• UDI-Device Identifier: 30382903812548
• UDI-Public: 30382903812548
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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: 11/30/2018
• Device Catalogue Number: 381254
• Device Lot Number: 3322471
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/30/2019
• 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