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

Catalog Number UNKNOWN

Device Problems Break (1069); Difficult to Remove (1528); 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  

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) usa has been used as a placeholder based on the reported phone area code.Device manufacture date: unknown.Investigation summary: as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.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.

Event Description

It was reported that 1 patient experienced an infection, and 2 experienced bleeding after the unspecified bd introsyte¿ introducers were used on them, requiring unspecified medical intervention.Additionally, 1 introducer's sheath 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 - 2 infection (within 24-48 hours after insertion of the introducer) - 1." "it was reported that bleeding & 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." "incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 1." "it was reported that incorrect/incomplete splitting resulted in patient or clinician injury that required medical or surgical intervention that patients have encountered when using the bd introsyte¿ introducers to facilitate the placement of midline.".

Event Description

It was reported that the unspecified bd introsyte¿ introducer's sheath 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 - 2 infection (within 24-48 hours after insertion of the introducer) - 1"."it was reported that bleeding & 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." "incorrect/incomplete splitting of the introducer upon its removal, requiring the removal of the device being inserted through the introducer - 1"."it was reported that.Incorrect/incomplete splitting resulted in patient or clinician injury that required medical or surgical intervention that.Patients have encountered when using the bd introsyte¿ introducers to facilitate the placement of midline".

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 unspecified bd introsyte¿ introducer's sheath did not split as intended during use.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, a150207.

• 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: 14192998
• MDR Text Key: 289966543
• Report Number: 2243072-2022-00555
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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: 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