MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD INTRODUCER INTROSYTE-N; INTRODUCER, CATHETER

Catalog Number	384021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd introducer introsyte-n wing broke during removal attempt.The following information was provided by the initial reporter: inserted a picc using a bd introsyte-n introducer.When i went to snap the introducer to peel the catheter away from the picc one wing of the introducer broke off.I was unable to peel the introducer away from the picc.As a result, the picc was dressed with the introducer remaining on the line.Myself and an nicu picc rn went to assess this line earlier this morning.We were able to remove the rest of the introducer from the line.However, after re-dressing the picc, it was noted to be leaking under the new dressing (immediately after placement) with the integrity of the line likely compromised by the many manipulations trying to remove the malfunctioning introducer.The infant is on critical medications and it took 4 piv attempts to re-site peripheral access.Once a piv was established, the leaking picc line was removed (without complication).This infant will now need another procedure for central access.On (b)(6) 2025 customer response: "the insertion note details: 2.0fr vygon picc placed in r antecubital vein.Lot#: 24g016d.Line trimmed to 21cm.Inserted to 17cm.Very deep upon initial x-ray.Dressing removed, found internal length to be at 16cm.Line pulled back by 2.5 cm.Current external length is 7.5cm.Upon inserting the picc the introducer did not tear away properly.The introducer remains on the external part of the line.2.What were the critical medications the patient was receiving? at the time of the event, the infant was a 9 day female with valvar pa-ivs with no rvdcc and tripartite rv, on pge.The critical medications noted were the pges to maintain the duct for circulation.3.Was there any delay in medication administration? not immediately quantifiable.The leaking picc line was left in situ with pges running (with the assumption that some amount of medication was still being delivered) until a piv could be established.There were no hemodynamic changes in the time between the leaking was noted in the picc and the time a new piv was secured.4.Did the patient have a new picc line placed? yes.The infant went to interventional radiology to have a new line inserted the following day.(leaking line removed on (b)(6) 1035, igt picc line placed on (b)(6) 1127).".
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Customer response on 14-jul-2025.While the safety incident includes details about the associated central line, the introducer failed to split as expected during line insertion.This resulted in difficulty removing the introducer (bd product) from around the picc line, causing damage to the picc line and subsequent new line insertion.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of introducer defective/damaged was confirmed upon inspection of the samples.Analysis of the sample showed that the reported defect was observed.The sheath are supplied to us by a third-party supplier, and they have been made aware of this issue.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INTRODUCER INTROSYTE-N
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22490742
• Report Number: 9610847-2025-00222
• Device Sequence Number: 8788613
• Product Code: DYB
• UDI-Device Identifier: 50382903840217
• UDI-Public: (01)50382903840217(17)271130(10)4355428
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K020834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 384021
• Device Lot Number: 4355428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 07/13/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown