MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTROSYTE INTRODUCERS; CATHETER INTRODUCER

Catalog Number UNKNOWN

Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

It was reported that 6 patients had infections and 16 patients had bleeding while using unspecified bd introsyte introducers.Additionally, 16 had the sheath not split as intended.The following information was provided by the initial reporter: "bleeding requiring medical intervention related to insertion of the introducer - 2.Hematoma related to insertion of the introducer - 2.Infection (within 24-48 hours after insertion of the introducer) - 2.Incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer -2".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default.The customer's address is unknown.Franklin lakes, new jersey (nj), usa has been used as a default.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Based on the available information we are not able to identify a root cause at this time.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.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 (b)(4) fda registration number has been used for the manufacture report number.

Manufacturer Narrative

The following fields were updated due to corrections: b.1.Adverse type: product problem.B.3.Event attributed to: other.B.5.Describe event or problem: it was reported that 16 unspecified bd introsyte introducers experienced the sheath not splitting as intended during use.No further information was provided.The following information was provided by the initial reporter: "incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer -2."incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 2"."incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 10"."incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer -2".D.4.Medical device expiration date: unknown.H.1.Type of reportable events: malfunction.H.2.No.Of events summarized: 16.H.4.Device manufacture date: unknown.H.6.Imdrf annex e grid: e2401.H.6.Imdrf annex f grid: f24.H.6.Imdrf annex a grid: a0202.

Event Description

It was reported that 16 unspecified bd introsyte introducers experienced the sheath not splitting as intended during use.No further information was provided.The following information was provided by the initial reporter: "incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer -2 "incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 2"."incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 10"."incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer -2".

• Brand Name: UNSPECIFIED BD INTROSYTE INTRODUCERS
• Type of Device: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14193379
• MDR Text Key: 289973252
• Report Number: 2243072-2022-00561
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 16
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other