MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED INSTYE¿ AUTOGUARD BC; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Tingling (2171); Numbness (2415)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical 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.(b)(6).

Event Description

It was reported that patient had paresthesia after insertion with an unspecified instye¿ autoguard bc.The following information was provided by the initial reporter, translated from (b)(6) to english: according to a report from the continuity nurse, a patient was punctured with an insyte ¿ autoguard bc catheter without incident.After the procedure (they do not report how long after), the patient started with paresthesia in the same limb.The clinic initiated an internal process to find out the causes, which included an electromyographic study to identify the cause.They did not formally claim, since they are not certain that the paresthesia was generated by the catheter.Currently, the information is in the hands of a medical audit and because there is an internal investigative process in progress, they can not provide more information.On (b)(6), the continuity nurse mentioned the situation, noting that she could not associate the situation with the use of the catheter because she was under audit.Today, after a sustained meeting to start the quality process, it delivers the data referred to at the beginning of this description.Report is extended as a result of eventual customer claim.

Event Description

It was reported that patient had paresthesia after insertion with an unspecified instye¿ autoguard bc.The following information was provided by the initial reporter, translated from spanish to english: according to a report from the continuity nurse, a patient was punctured with an insyte ¿ autoguard bc catheter without incident.After the procedure (they do not report how long after) the patient started with paresthesia in the same limb.The clinic initiated an internal process to find out the causes, which included an electromyographic study to identify the cause.They did not formally claim, since they are not certain that the paresthesia was generated by the catheter.Currently, the information is in the hands of a medical audit and because there is an internal investigative process in progress, they can not provide more information.On march 27, the continuity nurse mentioned the situation, noting that she could not associate the situation with the use of the catheter because she was under audit.Today, after a sustained meeting to start the quality process, it delivers the data referred to at the beginning of this description.Report is extended as a result of eventual customer claim.

Manufacturer Narrative

Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.Root cause is undetermined.

• Brand Name: UNSPECIFIED INSTYE¿ AUTOGUARD BC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8524479
• MDR Text Key: 142336818
• Report Number: 2243072-2019-00747
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

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
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other