MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PENCAN®; NEEDLE, CONDUCTION, ANESTH

Catalog Number 4502027

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).We received two pencan 27gx3 1/2" (0.42x88 mm) in original packaging and one used and broken off part of the raw cannula with tip from a pencan 27gx3 1/2" (0.42x88 mm) without packaging.The received samples were taken to a visual inspection.At the two samples in original packaging no damages or other deviations were detected.At the used sample (broken off part) the pencan cannula is broken off approx.33 mm away from the cannula tip.The structure of the break shows that the pencan cannula was bent before it breaks.The broken off part with the cannula hub was not handed over by the customer.In addition, the outside diameter of the pencan cannulas were measured according to the drawing.Nominal-value: 0.42 mm +0.01/-0 mm.Actual-values: used sample= 0.42 mm; original packed samples= both 0.42 mm.The measured values (outside diameters) of the pencan cannulas are in accordance with our specification.Afterwards, the two original packed samples were taken to a stiffness test (according to din en iso 9626 respectively test method 114007, pm: 2256).Nominal: max 0.34 mm / 3.4 n.Actual: 0.194 mm and 0.222 mm.Due to the stiffness test the samples meets our requirements.The broken piece was severly bent, and based on an evaluation of the broken surface the most likely cause of the break was repetitive bending back and forth.Summary and assessment: because the measured values and the stiffness test are within our specification, we assume of a problem during the application.Device history record (dhr): reviewed the dhr for the batch no.19a04g8f01, no abnormalities observed during the in-process and final control inspection.Note: this report is being filed for an item number that is not sold in the united states, however this item or similar items are sold in the united sates by b.Braun medical, inc.

Event Description

As reported by the user facility ((b)(4)): broken/needle.In accordance with customer: "during spinal anesthesia procedure for caesarian and at the moment of introduction of the pencil point needle, it was deformed and during the removal, part of the needle remained inside the patient.A small 0.5cm incision was made for exploration with hemostatic forceps, but it was not possible to capture the material.

• Brand Name: PENCAN®
• Type of Device: NEEDLE, CONDUCTION, ANESTH
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4842408332
• MDR Report Key: 9432171
• MDR Text Key: 183157836
• Report Number: 9610825-2019-00546
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: 4502027
• Device Lot Number: 19A04G8F01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other