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

Catalog Number	381357
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.(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 a catheter's packaging for a bd insyte-w ¿ iv catheter opened during storage.
Event or Problem Description
It was reported that a catheter's packaging for a bd insyte-w ¿ iv catheter opened during storage.
Additional Manufacturer Narrative
H.6.Investigation summary: a device history record review showed no non-conformance's associated with this issue during the production of this batch.One photo was received and evaluated.Open seal was observed from the blister package in the photo, however the blister package belong to both the 20ga and 22ga insyte family.The reported batch belong to 16ga insyte family, and hence the blister package in the photo does not belong to the reported batch.Nevertheless, observed from the photo that 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.2 actual unused samples were returned for investigation.The samples were not decontaminated.The samples were observed not sealed at the 4 corners of the packaging.The samples were subjected to visual examination and observe that the 4 corners 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.Conclusion: 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.

• Brand Name: BD INSYTE-W ¿ IV CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8294165
• Report Number: 8041187-2019-00123
• Device Sequence Number: 13950892
• Product Code: FOZ
• UDI-Device Identifier: 00382903813575
• UDI-Public: 00382903813575
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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: 07/31/2019
• Device Catalogue Number: 381357
• Device Lot Number: 4205157
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 03/11/2019
• 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