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

Catalog Number	381254
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
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, a supplemental report will be filed.
Event or Problem Description
It was reported before use of the bd insyte¿ autoguard¿ bc shielded iv catheter the seal had already been broken.
Event or Problem Description
It was reported before use of the bd insyte¿ autoguard¿ bc shielded iv catheter the seal had already been broken.
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.1 actual sample were returned for investigation.The actual sample was subjected to visual inspection.Open seal was observed on the 4 corners of 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.(ref.: erf-i-096) therefore, no assignable root cause can be established.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8047566
• Report Number: 8041187-2018-00406
• Device Sequence Number: 1644652
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: 12/31/2019
• Device Catalogue Number: 381254
• Device Lot Number: 4351328
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 02/01/2019
• 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