MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SAF-T-INTIMA CATHETER; INTERVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that an unspecified number of an unspecified bd saf-t-intima catheter experienced no label or no missing label information which was noticed during use.The following information was provided by the initial reporter: i am the senior sister on neuro itu and would like to share an incident that happened on the unit on (b)(6) 2019.We feel it is important to notify you in case there has been any similar incidents reported to your company.Apologies for the late notification as it was overlooked at the time of the incident but i still feel it is important to share this information.History: the unit had a palliative care patient, prior to transfer to the ward a nurse on critical care inserted a bd saf ¿t- intima cannula into the patient¿s abdomen to infuse end of life medication however the guideline was not removed.The user was not aware there was a guide wire as there was no documentation on the needle package to support this information and the package was very similar to the package of the needle that does not contain guidewire.(b)(6) 2018 - patient transferred from nitu with needle in situ.On (b)(6) 2018 - confirmed by senior sister that needle and wire both in situ.Both removed on identification.Actions post raising ir1: staff involved were asked for statements.Staff undertook reflections about the incident.On (b)(6) 2019 anaesthetic division undertook a round table.Route cause analysis investigation was undertaken so lessons learned could be established and shared.Patient has come to no harm.Shared learning across all 3 critical cares.Mhra should be raised to the company about the packaging.Since this incident staff have had training with this product and there has been no further incidents across all 3 critical care units.

Manufacturer Narrative

H.6.Investigation summary as there was no sample, product code, or lot number available for this incident, our quality team was unable to evaluate the product packaging mentioned within the reported complaint.Based on the limited investigation results, no issues could be identified with the saf-t-intima product.No dhr review can be carried out as lot number is unknown.It is critical that the instructions for use (ifu) are always referenced when using the saf-t-intima product to ensure that the product is being used as recommended.At this time, further corrective action has not been determined necessary.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

Event Description

It was reported that an unspecified number of an unspecified bd saf-t-intima catheter experienced no label or no missing label information which was noticed during use.The following information was provided by the initial reporter: i am the senior sister on neuro itu and would like to share an incident that happened on the unit (b)(6) 2019.We feel it is important to notify you in case there has been any similar incidents reported to your company apologies for the late notification as it was overlooked at the time of the incident but i still feel it is important to share this information.History the unit had a palliative care patient, prior to transfer to the ward a nurse on critical care inserted a bd saf ¿t- intima cannula into the patient¿s abdomen to infuse end of life medication however the guideline was not removed.The user was not aware there was a guide wire as there was no documentation on the needle package to support this information and the package was very similar to the package of the needle that does not contain guidewire.28.02.18 - patient transferred from nitu with needle in situ.01.03.18 - confirmed by senior sister that needle and wire both in situ.Both removed on identification.Actions post raising ir1 ¿ staff involved were asked for statements.¿ staff undertook reflections about the incident ¿ on (b)(6) 2019 anaesthetic division undertook a round table.¿ route cause analysis investigation was undertaken so lessons learned could be established and shared.¿ patient has come to no harm.¿ shared learning across all 3 critical cares ¿ mhra should be raised to the company about the packaging.Since this incident staff have had training with this product and there has been no further incidents across all 3 critical care units.

• Brand Name: UNSPECIFIED BD SAF-T-INTIMA CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9541079
• MDR Text Key: 178224348
• Report Number: 2243072-2020-00002
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other