MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA; PISTON SYRINGE

Catalog Number	309597
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd integra needle was clogged/blocked.The following information was provided by the initial reporter: "the patient is advising that injection did not work today.The patient stated that the medication would no pass through the needle and eventually came out of the top of the syringe instead and did not inject through the needle.The patient will use other vial from kit for dose today.No additional information provided.".
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.
Event or Problem Description
Material#: 309597, batch#: 2263232.It was reported by the customer that the patient is advising that injection did not work today.The patient stated that the medication would no pass through the needle and eventually came out of the top of the syringe instead and did not inject through the needle.The patient will use other vial from kit for dose today.No additional information provided.Verbatim: rcc received a complaint via email.Email(s) attached.External evaluation is required for xxx tw (b)(4) ¿ defective device product: gattex bd plastic dosing syringe (1 ml) with needle attached (26g, 5/8 inch) bd syringe lot number(s): 2263232.The patient is advising that injection did not work today.The patient stated that the medication would no pass through the needle and eventually came out of the top of the syringe instead and did not inject through the needle.The patient will use other vial from kit for dose today.No additional information provided.Status: requesting external evaluation.Country of origin: united states.Sample / photo availability: no sample or photos were provided to xxx.Ae: no ae reported.Patient identifiers available? (i.E.Gender, weight, ethnicity, etc.): patient identifiers will not be available for any investigation request.No additional information provided.Inv due by: (b)(6) 2023.

• Brand Name: BD INTEGRA
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18166905
• Report Number: 1213809-2023-01290
• Device Sequence Number: 12581609
• Product Code: FMF
• UDI-Device Identifier: 30382903095972
• UDI-Public: (01)30382903095972
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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 Catalogue Number: 309597
• Device Lot Number: 2263232
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 11/18/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown