MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SPINAL¿ NEEDLE; SPINAL NEEDLE

Catalog Number 405259

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd spinal¿ needle has a loose connection and leaked.No serious injury or medical intervention was reported.

Event Description

It was reported that bd spinal¿ needle has a loose connection and leaked.No serious injury or medical intervention was reported.

Manufacturer Narrative

H.6.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Dhr: n/a - no lot.Inspections and test/inspections y tests.Following inspections are performed at according to ae-500 procedure (current version) to verify the correct quality of the luer taper: 12 samples/24h according to (b)(4) (limits= 4,290 - 4,330 mm).Leakage test (positive pressure) is performed according to ae-600 and (b)(4) procedures (current version).Inspections during packing and packaging process are done according to ae-303 (current version).

• Brand Name: BD SPINAL¿ NEEDLE
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8228755
• MDR Text Key: 132534563
• Report Number: 3003152976-2018-00589
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405259
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other