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

Catalog Number UNKNOWN

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Insufficient Information (4580)

Event Date 03/31/2022

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.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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is unknown.(b)(6) has been used as a default.Device manufacture date: unknown.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.

Event Description

It was reported that 8 patients experienced bleeding, and 8 patients experienced infections after the unspecified bd introsyte¿ introducers were used on them, requiring unspecified medical intervention.Additionally, 12 introducer's sheaths did not split as intended during use.No further information was provided.The following information was provided by the initial reporter: "bleeding requiring medical intervention related to insertion of the introducer - 3.Infection (within 24-48 hours after insertion of the introducer) - 3 incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 5" "it was reported that bleeding.Incorrect/incomplete splitting & infection (within 24-48 hours after insertion of the introducer) resulted in patient or clinician injury that required medical or surgical intervention when using the bd introsyte¿ introducers." "bleeding requiring medical intervention 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 - 4." "it was reported that bleeding.Incorrect/incomplete splitting & infection (within 24-48 hours after insertion of the introducer) resulting in patient or clinician injury that required medical or surgical intervention when using the bd introsyte¿ introducers to facilitate the placement of indwelling central venous catheters." "bleeding requiring medical intervention related to insertion of the introducer - 3.Infection (within 24-48 hours after insertion of the introducer) - 3 incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 3." "it was reported that bleeding.Incorrect/incomplete splitting & infection (within 24-48 hours after insertion of the introducer) resulted in patient or clinician injury that required medical or surgical intervention that your patients have encountered when using the bd introsyte¿ introducers to facilitate the placement of guidewires.".

Event Description

It was reported that 12 unspecified bd introsyte¿ introducers introducer's sheaths did not split 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 - 5." "incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 4." "incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 3.".

Manufacturer Narrative

The following fields were updated due to corrections: b.5.Describe event or problem: it was reported that 12 unspecified bd introsyte¿ introducers introducer's sheaths did not split 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 - 5." "incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 4"."incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 3".H.2.No.Of events summarized: 12.

Event Description

It was reported that 12 unspecified bd introsyte¿ introducers introducer's sheaths did not split as intended during use.No further information was provided.The following information was provided by the initial reporter: "bleeding requiring medical intervention related to insertion of the introducer - 3.Infection (within 24-48 hours after insertion of the introducer) - 3.Incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 5." "it was reported that bleeding.Incorrect/incomplete splitting & infection (within 24-48 hours after insertion of the introducer) resulted in patient or clinician injury that required medical or surgical intervention when using the bd introsyte¿ introducers." "bleeding requiring medical intervention 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 - 4." "it was reported that bleeding.Incorrect/incomplete splitting & infection (within 24-48 hours after insertion of the introducer) resulting in patient or clinician injury that required medical or surgical intervention when using the bd introsyte¿ introducers to facilitate the placement of indwelling central venous catheters." "bleeding requiring medical intervention related to insertion of the introducer - 3.Infection (within 24-48 hours after insertion of the introducer) - 3.Incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 3." "it was reported that bleeding.Incorrect/incomplete splitting & infection (within 24-48 hours after insertion of the introducer) resulted in patient or clinician injury that required medical or surgical intervention that your patients have encountered when using the bd introsyte¿ introducers to facilitate the placement of guidewires.".

Manufacturer Narrative

The following fields were updated due to corrections: b.1.Adverse type: product problem.B.5.Describe event or problem: it was reported that the patient experienced an infection that occurred after the unspecified bd introsyte¿ introducer was used on them, and had to have medical intervention as a result.No further information was provided.B.6.Relevant tests/laboratory data: none reported.H.1.Type of reportable events: malfunction.H.6.Imdrf annex e grid: e2401.H.6.Imdrf annex f grid: f24.H.6.Imdrf annex a grid: a0401.

• Brand Name: UNSPECIFIED BD INTROSYTE¿ INTRODUCER
• 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: 14188192
• MDR Text Key: 289895776
• Report Number: 2243072-2022-00537
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 12
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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): Other