MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD BLUNT FILTER NRFIT; NEEDLE

Catalog Number	400066
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the bd blunt filter nrfit was used in a study and that the participant reported urinary retention.The following information was provided by the initial reporter: the above mentioned customer is participating in the (b)(4) study.The adverse event ¿ urinary retention¿ was reported on (b)(6) 2024 and was resolved the same day.Bd syringe nrfit (catalog number/type/size).400051/syringe nrfit slip/5ml.Bd syringe nrfit lot number: 83149.Ancillary device used (catalogue number/type/size).400066/bd blunt filter nrfit needle/18g x 1 1/2(1.2 mm x 40 mm).Bd blunt fill or blunt filter nrfit needle lot number: 3045501.The adverse event ¿ urinary retention¿ was reported on (b)(6) 2024 and was resolved the same day.Severity: mild.Site assessed the event at first as not related to every thing, but after being queried for more details, has now change the assessment to ¿possible¿ related to procedure.Relationship to spinal needle: not related.Relationship to syringe: not related.Relationship to introducer: not related.Relationship to ancillary devices: not related.Relationship to procedure: possible.Subject was treated with urinary catheter.Site confirmed in a query response that urinary retention occurred after 4, 5 hours of the procedure and there is no history of urinary retention in the subject.There were no complications occurred during the procedure.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Follow up report for correction.The date received by manufacturer was incorrect in the initial mdr, date should be (b)(6)2024.H3 other text : see narrative below.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) follow up #2 report for corrections.This complaint was found to be a duplicate after the mdr was submitted, please refer to (b)(4).
Event or Problem Description
This complaint was found to be a duplicate after the mdr was submitted.

• Brand Name: BD BLUNT FILTER NRFIT
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18678412
• Report Number: 9614033-2024-00010
• Device Sequence Number: 7395997
• Product Code: GAA
• UDI-Device Identifier: 00382904000660
• UDI-Public: (01)00382904000660
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 400066
• Device Lot Number: 3045501
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 01/29/2024; 01/29/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 02/15/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown