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

Catalog Number	381267
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that before use of the bd insyte¿ iv catheter non-winged many catheters have problems with the packaging.They are open while they are stored.
Event or Problem Description
It was reported that before use of the bd insyte¿ iv catheter non-winged many catheters have problems with the packaging.They are open while they are stored.
Additional Manufacturer Narrative
H.6.Investigation: one photo was received and evaluated.Open seal was observed from the blister package in the photo.However, the samples shown in the photo are belong to 22ga insyte family which is not from the reported batch.The reported batch belong to 14ga insyte family.2 actual (unused) samples were returned for investigation.The samples were not decontaminated.Opened seal was observed on the samples.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.The complaint is confirmed and product is out of specification.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.Dhr was performed and no quality notification had been raised for a similar nonconformance.

• Brand Name: BD INSYTE¿ IV CATHETER NON-WINGED
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8358242
• Report Number: 8041187-2019-00164
• Device Sequence Number: 2024419
• Product Code: FOZ
• UDI-Device Identifier: 30382903812678
• UDI-Public: 30382903812678
• 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): 03/21/2019

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: 04/30/2019
• Device Catalogue Number: 381267
• Device Lot Number: 4107143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 03/21/2019
• 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