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

Catalog Number	384021
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd introsyte-n¿ precision introducer right wing broke off.This is 1 of 3 related events.The following information was provided by the initial reporter: "i am one of the nicu line insertion nurses at cook children¿s and i am reaching out regarding our neopicc introducers (26g 1.9fr bd introsyte-n).I am including my partner, xxx on this email as well.In the past few weeks we have had three instances where the introducer did not break-away/separate appropriately as designed, one of which resulted in having to replace the newly inserted picc.Additional information received: here is the information regarding the recent incidents we have had regarding the picc introducers breaking.All three introducers broke at the same spot.The right wing broke off completely, instead of breaking down the center of the introducer in order to peel it away.I¿ve included a picture below-this was from the first patient, that occurred on (b)(6) 2023.Are you able to provide the incident dates for the three instances? (b)(6) 2023.Are you able to provide any patient identifiers including: age/ date of birth, sex, weight, ethnicity, race, other relevant history including preexisting medical conditions? all three patients were neonates (two of them premature) in our nicu.The first case was a 5 day old 26 week preemie, weighing 430g; the second was a 3 day old term neonate weighing 2970g (this patient required a new picc as the introducer could not be removed) and the third patient was a 7 week old former 24 week preemie weighing 1760g.What is the patient outcome? are there any adverse events/serious injuries? one of the patient¿s required the newly placed picc to be removed (as the introducer could not be removed without removing the line) and a new picc to be placed which required a new needle stick and further x-rays to confirm placement for the second line.No other serious injuries or adverse outcomes were noted for these patients.Was there a delay of, or change in, the course of treatment due to the event? no.What type of procedure is being performed? all occurred during picc placement, after x-ray confirmed placement, when the introducer was attempted to be removed via peel-away method.What was the medication/fluid in use at the time of the event? n/a.
Additional Manufacturer Narrative
A.2.Date of birth: patient¿s birthday was not provided, dob : (b)(6) 2023 was used based on age of patient.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.E1.Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.
Event or Problem Description
It was reported that the bd introsyte-n¿ precision introducer right wing broke off.This is 1 of 3 related events.The following information was provided by the initial reporter: "i am one of the nicu line insertion nurses at (b)(6) and i am reaching out regarding our neopicc introducers (26g 1.9fr bd introsyte-n).I am including my partner, xxx on this email as well.In the past few weeks we have had three instances where the introducer did not break-away/separate appropriately as designed, one of which resulted in having to replace the newly inserted picc.Additional information received.Here is the information regarding the recent incidents we have had regarding the picc introducers breaking.All three introducers broke at the same spot.The right wing broke off completely, instead of breaking down the center of the introducer in order to peel it away.I¿ve included a picture below-this was from the first patient, that occurred on (b)(6) 23.Are you able to provide the incident dates for the three instances? (b)(6) 23.Are you able to provide any patient identifiers including: age/ date of birth, sex, weight, ethnicity, race, other relevant history including preexisting medical conditions? all three patients were neonates (two of them premature) in our nicu.The first case was a 5 day old 26 week preemie, weighing 430g; the second was a 3 day old term neonate weighing 2970g (this patient required a new picc as the introducer could not be removed) and the third patient was a 7 week old former 24 week preemie weighing 1760g.What is the patient outcome? are there any adverse events/serious injuries? one of the patient¿s required the newly placed picc to be removed (as the introducer could not be removed without removing the line) and a new picc to be placed which required a new needle stick and further x-rays to confirm placement for the second line.No other serious injuries or adverse outcomes were noted for these patients.Was there a delay of, or change in, the course of treatment due to the event? no.What type of procedure is being performed? all occurred during picc placement, after x-ray confirmed placement, when the introducer was attempted to be removed via peel-away method.What was the medication/fluid in use at the time of the event? n/a.
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of introducer defective / damaged was confirmed upon inspection of the photo.The photo clearly shows the reported defect.Bd determined that the cause of the failure was likely associated to our supplier¿s process.A notification of the failure has been sent to our supplier to help mitigate future occurrences of the failure mode.Production records were reviewed, and this batch met our manufacturing product specification requirements.

• Brand Name: BD INTROSYTE-N¿ PRECISION INTRODUCER
• Common Device Name: INTRAVASCULAR 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): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17079817
• Report Number: 9610847-2023-00140
• Device Sequence Number: 20398274
• Product Code: FOZ
• UDI-Device Identifier: 00382903840212
• UDI-Public: (01)00382903840212
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K974764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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: Other
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 384021
• Device Lot Number: 3019761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 5 DA
• Patient Sex: Unknown
• Patient Weight: 430 KG