MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10062818
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and/or 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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the unspecified bd¿ extension set there was leakage.The following was received by the initial reporter: platelets to be administered in room 698 - tubing was prepped and platelet bag was spiked.Unclear if tubing malfunction and/or bag was spiked improperly, but after hanging and trying to clear line, tubing detached from bag and some contents spilled onto floor and patient's foot.Patient was unharmed and checked throughout day.Blood bank was called and confirmed that tubing/ bag did not need to be saved as no harm came to patient.New platelets were acquired and rehung, and patient did received platelets during shift as required.What was the patient outcome? no conceivable harm.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of tubing set detaching from the bag could not be verified due to the product not being returned for failure investigation.Device history record review for model 10062818 lot number 21115330 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.
Event or Problem Description
No additional information was provided: material#: 10062818.Batch number#: 21115330.It was reported by customer that platelets to be administered in room 698 - tubing was prepped and platelet bag was spiked.Unclear if tubing malfunction and/or bag was spiked improperly, but after hanging and trying to clear line, tubing detached from bag and some contents spilled onto floor and patient's foot.Patient was unharmed and checked throughout day.Blood bank was called and confirmed that tubing/ bag did not need to be saved as no harm came to patient.New platelets were acquired and rehung, and patient did received platelets during shift as required.Verbatim#: rcc received the complaint via email.Email(s) as attached.Icare: 293882 ¿platelets to be administered in room 698 - tubing was prepped and platelet bag was spiked.Unclear if tubing malfunction and/or bag was spiked improperly, but after hanging and trying to clear line, tubing detached from bag and some contents spilled onto floor and patient's foot.Patient was unharmed and checked throughout day.Blood bank was called and confirmed that tubing/ bag did not need to be saved as no harm came to patient.New platelets were acquired and rehung, and patient did received platelets during shift as required.¿ - date of event: 9/20/23 - was there any leakage? yes - did the device/material separated or did it break/crack at collars? yes (assuming collars is near drip chamber) - was issue noted before or during use? yes - was there any patient involvement? yes - any adverse events or serious injury reported to patient or healthcare professional? blood product exposure - what was the patient outcome? no conceivable harm - was there any delay of, or change in, the course of treatment due to this event? yes, delay of transfusion.New blood products needed to be obtained.Wasted bag of platelets.- what procedure was being performed? administration of blood platelets.- what medication was used in the procedure? unsure.

• Brand Name: UNSPECIFIED BD¿ EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana NJ 22244
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17873247
• Report Number: 2243072-2023-01789
• Device Sequence Number: 20260008
• Product Code: FPA
• UDI-Device Identifier: 07613203019668
• UDI-Public: (01)07613203019668
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 11/18/2024
• Device Catalogue Number: 10062818
• Device Lot Number: 21115330
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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 Sex: Unknown